<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03288493</url>
  </required_header>
  <id_info>
    <org_study_id>P-BCMA-101-001</org_study_id>
    <nct_id>NCT03288493</nct_id>
  </id_info>
  <brief_title>P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)</brief_title>
  <official_title>Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poseida Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Institute for Regenerative Medicine (CIRM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Poseida Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple&#xD;
      cohort study; a multiple dose cycle administration cohort study; and a combination&#xD;
      administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in&#xD;
      patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and&#xD;
      safety study. Rimiducid may be administered as indicated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an&#xD;
      open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis&#xD;
      will be performed to obtain peripheral blood mononuclear cells which will be sent to a&#xD;
      manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the&#xD;
      investigational site and, after a standard chemotherapy based conditioning regimen, will be&#xD;
      administered to the patient across 1-3 infusions, with or without combination therapy.&#xD;
      Treated patients will undergo serial measurements of safety, tolerability and response.&#xD;
      Rimiducid may be administered as indicated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Phase I portion of the study was completed. The phase II portion of the study was terminated&#xD;
    early to focus on an Allogeneic BCMA CAR-T program.&#xD;
  </why_stopped>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">April 27, 2022</completion_date>
  <primary_completion_date type="Actual">April 27, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Phase 1: open label, 3 + 3 design of dose-escalating cohorts Phase 2: open label, administered as a total dose</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: Assess the Safety of P-BCMA-101</measure>
    <time_frame>Baseline through Day 28</time_frame>
    <description>Incidence and severity of treatment-emergent adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1: Maximum Tolerated Dose of P-BCMA-101</measure>
    <time_frame>Baseline through Day 28</time_frame>
    <description>Rate of dose limiting toxicities (DLT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Assess the Safety of P-BCMA-101</measure>
    <time_frame>Baseline through 24 months</time_frame>
    <description>Incidence and severity of treatment-emergent adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)</measure>
    <time_frame>Baseline through 24 months</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)</measure>
    <time_frame>Baseline through 24 months</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1:Assess the Safety of P-BCMA-101</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Incidence and severity of treatment-emergent adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1:Assess the Feasibility P-BCMA-101</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Ability to generate protocol-prescribed doses of P-BCMA-101.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluate Efficacy Endpoints (IL-6)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Rate of IL-6 antagonist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluate Efficacy Endpoints (C)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Corticosteroid Use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluate Efficacy Endpoints (R)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Rimiducid Use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluate Efficacy Endpoints (OS)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluate Efficacy Endpoints (PFS)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluate Efficacy Endpoints (TTR)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluate Efficacy Endpoints (MRD)</measure>
    <time_frame>Baseline through Month 24</time_frame>
    <description>Minimum residual disease negative rate</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Phase 1: P-BCMA-101 CAR-T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: P-BCMA-101 CAR-T Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CAR-T cells administered via intravenous infusion as a total dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>P-BCMA-101 CAR-T cells</intervention_name>
    <description>P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a &quot;safety switch&quot; gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.</description>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort A)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort B)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort C)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)</arm_group_label>
    <arm_group_label>Phase 1: P-BCMA-101 CAR-T cells</arm_group_label>
    <arm_group_label>Phase 2: P-BCMA-101 CAR-T Cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rimiducid</intervention_name>
    <description>Rimiducid (safety switch activator) may be administered as indicated.</description>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort A)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort B)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells (Cohort C)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)</arm_group_label>
    <arm_group_label>Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)</arm_group_label>
    <arm_group_label>Phase 1: P-BCMA-101 CAR-T cells</arm_group_label>
    <arm_group_label>Phase 2: P-BCMA-101 CAR-T Cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females, ≥18 years of age&#xD;
&#xD;
          -  Must have a confirmed diagnosis of active MM&#xD;
&#xD;
          -  Must have measurable MM&#xD;
&#xD;
          -  Must have relapsed / refractory MM, having received treatment with proteasome&#xD;
             inhibitor and IMiD [Phase 2: Must have relapsed / refractory MM, and refractory to&#xD;
             last line of therapy, having received treatment with proteasome inhibitor, an IMiD,&#xD;
             CD38 targeted therapy and undergone autologous stem cell transplant (ASCT) or not a&#xD;
             candidate for ASCT.]&#xD;
&#xD;
          -  Must have adequate hepatic, renal, cardiac and hematopoietic function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is pregnant or lactating&#xD;
&#xD;
          -  Has inadequate venous access and/or contraindications to leukapheresis&#xD;
&#xD;
          -  Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia,&#xD;
             POEMS syndrome, disseminated intravascular coagulation, leukostasis, amyloidosis,&#xD;
             significant autoimmune, CNS or other malignant disease&#xD;
&#xD;
          -  Has an active second malignancy (not disease-free for at least 5 years) in addition to&#xD;
             MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell&#xD;
             skin carcinoma.&#xD;
&#xD;
          -  Has active autoimmune disease&#xD;
&#xD;
          -  Has a history of significant central nervous system (CNS) disease, such as stroke,&#xD;
             epilepsy, etc.&#xD;
&#xD;
          -  Has an active systemic infection&#xD;
&#xD;
          -  Has hepatitis B or C virus, human immunodeficiency virus (HIV), or human&#xD;
             T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome.&#xD;
&#xD;
          -  Has any psychiatric or medical disorder that would preclude safe participation in&#xD;
             and/or adherence to the protocol&#xD;
&#xD;
          -  Has receiving immunosuppressive or other contraindicated therapies within the excluded&#xD;
             time frame from entry&#xD;
&#xD;
          -  Has CNS metastases or symptomatic CNS involvement&#xD;
&#xD;
          -  Has a history of having undergone allogeneic stem cell transplantation, or any other&#xD;
             allogeneic or xenogeneic transplant, or has undergone autologous transplantation&#xD;
             within 90 days.&#xD;
&#xD;
          -  Unable to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation.&#xD;
             (Cohorts R and RP only).&#xD;
&#xD;
          -  History of thromboembolic disease within the past 6 months, regardless of&#xD;
             anticoagulation (Cohorts R and RP only).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajesh Belani, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Sponsor Executive Medical Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Blood Cancer Institute</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Greenebaum Comprehensive Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State - Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute at Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <results_first_submitted>April 25, 2023</results_first_submitted>
  <results_first_submitted_qc>May 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2023</results_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAR-T cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03288493/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Phase 1: P-BCMA-101 CAR-T Cells</title>
          <description>Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="P2">
          <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)</title>
          <description>Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="P3">
          <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)</title>
          <description>Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="P4">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion.</description>
        </group>
        <group group_id="P5">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="P6">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="P7">
          <title>Phase 2: P-BCMA-101 CAR-T Cells</title>
          <description>CAR-T cells administered via intravenous infusion as a total dose</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="16"/>
                <participants group_id="P7" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="16"/>
                <participants group_id="P7" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Significant progression of malignancy requiring alternative, medical, radiation or surgical interven</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Termination of the study by the PI, the sponsor, the study funder, the IRB/IEC or the FDA</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>other reason not listed above</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Phase 1: P-BCMA-101 CAR-T Cells</title>
          <description>Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="B2">
          <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)</title>
          <description>Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="B3">
          <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)</title>
          <description>Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="B4">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="B5">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="B6">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="B7">
          <title>Phase 2: P-BCMA-101 CAR-T Cells</title>
          <description>CAR-T cells administered via intravenous infusion as a total dose</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="5"/>
            <count group_id="B6" value="16"/>
            <count group_id="B7" value="3"/>
            <count group_id="B8" value="105"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="14"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Phase 1: Assess the Safety of P-BCMA-101</title>
        <description>Incidence and severity of treatment-emergent adverse events</description>
        <time_frame>Baseline through Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase 1: P-BCMA-101 CAR-T Cells</title>
            <description>Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)</title>
            <description>Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)</title>
            <description>Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)</title>
            <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)</title>
            <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)</title>
            <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1: Assess the Safety of P-BCMA-101</title>
          <description>Incidence and severity of treatment-emergent adverse events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>TEAE Related to P-BCMA-101</title>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TEAE Not Related to P-BCMA-101</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 1: Maximum Tolerated Dose of P-BCMA-101</title>
        <description>Rate of dose limiting toxicities (DLT)</description>
        <time_frame>Baseline through Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase 1: P-BCMA-101 CAR-T Cells</title>
            <description>Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)</title>
            <description>Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)</title>
            <description>Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)</title>
            <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)</title>
            <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)</title>
            <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2: P-BCMA-101 CAR-T Cells</title>
            <description>CAR-T cells administered via intravenous infusion as a total dose</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1: Maximum Tolerated Dose of P-BCMA-101</title>
          <description>Rate of dose limiting toxicities (DLT)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="NA">DLT not applicable for Phase 2 participants</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Assess the Safety of P-BCMA-101</title>
        <description>Incidence and severity of treatment-emergent adverse events</description>
        <time_frame>Baseline through 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: P-BCMA-101 CAR-T Cells</title>
            <description>CAR-T cells administered via intravenous infusion as a total dose</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Assess the Safety of P-BCMA-101</title>
          <description>Incidence and severity of treatment-emergent adverse events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>TEAE Related to P-BCMA-101</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TEAE Not Related to P-BCMA-101</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).</description>
        <time_frame>Baseline through 24 months</time_frame>
        <population>Independent Review Committee (IRC) was not formed to assess ORR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: P-BCMA-101 CAR-T Cells</title>
            <description>CAR-T cells administered via intravenous infusion as a total dose</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)</title>
          <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).</description>
          <population>Independent Review Committee (IRC) was not formed to assess ORR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
        <time_frame>Baseline through 24 months</time_frame>
        <population>Independent Review Committee (IRC) was not formed to assess DOR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: P-BCMA-101 CAR-T Cells</title>
            <description>CAR-T cells administered via intravenous infusion as a total dose</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)</title>
          <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
          <population>Independent Review Committee (IRC) was not formed to assess DOR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1:Assess the Safety of P-BCMA-101</title>
        <description>Incidence and severity of treatment-emergent adverse events</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1:Assess the Feasibility P-BCMA-101</title>
        <description>Ability to generate protocol-prescribed doses of P-BCMA-101.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies</title>
        <description>Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)</title>
        <description>Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Evaluate Efficacy Endpoints (IL-6)</title>
        <description>Rate of IL-6 antagonist</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Evaluate Efficacy Endpoints (C)</title>
        <description>Corticosteroid Use</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Evaluate Efficacy Endpoints (R)</title>
        <description>Rimiducid Use</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Evaluate Efficacy Endpoints (OS)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Evaluate Efficacy Endpoints (PFS)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Evaluate Efficacy Endpoints (TTR)</title>
        <description>According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:&#xD;
Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Evaluate Efficacy Endpoints (MRD)</title>
        <description>Minimum residual disease negative rate</description>
        <time_frame>Baseline through Month 24</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through Month 24</time_frame>
      <desc>Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.</desc>
      <group_list>
        <group group_id="E1">
          <title>Phase 1: P-BCMA-101 CAR-T Cells</title>
          <description>Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="E2">
          <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)</title>
          <description>Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="E3">
          <title>Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)</title>
          <description>Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="E4">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="E5">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="E6">
          <title>Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)</title>
          <description>Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.</description>
        </group>
        <group group_id="E7">
          <title>Phase 2: P-BCMA-101 CAR-T Cells</title>
          <description>CAR-T cells administered via intravenous infusion as a total dose</description>
        </group>
        <group group_id="E8">
          <title>Retreatment</title>
          <description>If a subject's disease progressed and sufficient P-BCMA-101 cells were available from initial manufacturing, a subject may have received an additional P-BCMA-101 infusion at up to the highest dose level that had completed DLT assessment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Functional gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pleural infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Progressive multifocal leukoencephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Klebsiella infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pneumonia adenoviral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Neurotoxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="16"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="189" subjects_affected="48" subjects_at_risk="69"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" events="12" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E6" events="32" subjects_affected="13" subjects_at_risk="16"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" events="6" subjects_affected="3" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="132" subjects_affected="32" subjects_at_risk="69"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" events="8" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E7" events="4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="92" subjects_affected="33" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="5" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="5" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E6" events="10" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="49" subjects_affected="20" subjects_at_risk="69"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="10" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E7" events="8" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="33" subjects_affected="25" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="23" subjects_affected="19" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="18" subjects_affected="14" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="27" subjects_affected="22" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="26" subjects_affected="19" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="13" subjects_affected="7" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="30" subjects_affected="18" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="5" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="15" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rajesh Belani, MD, Vice President Clinical Development</name_or_title>
      <organization>Poseida Therapeutics</organization>
      <phone>858-779-3100</phone>
      <email>rbelani@poseida.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03288493
org study id: P-BCMA-101-001
nct id: NCT03288493
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple
      cohort study; a multiple dose cycle administration cohort study; and a combination
      administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in
      patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and
      safety study. Rimiducid may be administered as indicated.
Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an
      open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis
      will be performed to obtain peripheral blood mononuclear cells which will be sent to a
      manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the
      investigational site and, after a standard chemotherapy based conditioning regimen, will be
      administered to the patient across 1-3 infusions, with or without combination therapy.
      Treated patients will undergo serial measurements of safety, tolerability and response.
      Rimiducid may be administered as indicated.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Phase 1: open label, 3 + 3 design of dose-escalating cohorts Phase 2: open label, administered as a total dose
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1: Assess the Safety of P-BCMA-101
time frame: Baseline through Day 28
description: Incidence and severity of treatment-emergent adverse events
measure: Phase 1: Maximum Tolerated Dose of P-BCMA-101
time frame: Baseline through Day 28
description: Rate of dose limiting toxicities (DLT)
measure: Phase 2: Assess the Safety of P-BCMA-101
time frame: Baseline through 24 months
description: Incidence and severity of treatment-emergent adverse events
measure: Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)
time frame: Baseline through 24 months
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
measure: Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)
time frame: Baseline through 24 months
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
measure: Phase 1:Assess the Safety of P-BCMA-101
time frame: Baseline through Month 24
description: Incidence and severity of treatment-emergent adverse events
measure: Phase 1:Assess the Feasibility P-BCMA-101
time frame: Baseline through Month 24
description: Ability to generate protocol-prescribed doses of P-BCMA-101.
measure: Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
measure: Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
measure: Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
measure: Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.
measure: Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.
measure: Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies
time frame: Baseline through Month 24
description: Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
measure: Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)
time frame: Baseline through Month 24
description: Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
measure: Phase 2: Evaluate Efficacy Endpoints (IL-6)
time frame: Baseline through Month 24
description: Rate of IL-6 antagonist
measure: Phase 2: Evaluate Efficacy Endpoints (C)
time frame: Baseline through Month 24
description: Corticosteroid Use
measure: Phase 2: Evaluate Efficacy Endpoints (R)
time frame: Baseline through Month 24
description: Rimiducid Use
measure: Phase 2: Evaluate Efficacy Endpoints (OS)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.
measure: Phase 2: Evaluate Efficacy Endpoints (PFS)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.
measure: Phase 2: Evaluate Efficacy Endpoints (TTR)
time frame: Baseline through Month 24
description: According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:
Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
measure: Phase 2: Evaluate Efficacy Endpoints (MRD)
time frame: Baseline through Month 24
description: Minimum residual disease negative rate
arm group label: Phase 1: P-BCMA-101 CAR-T cells
arm group type: Experimental
description: Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
arm group type: Experimental
description: Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort B)
arm group type: Experimental
description: Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort C)
arm group type: Experimental
description: Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)
arm group type: Experimental
description: Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)
arm group type: Experimental
description: Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)
arm group type: Experimental
description: Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
arm group label: Phase 2: P-BCMA-101 CAR-T Cells
arm group type: Experimental
description: CAR-T cells administered via intravenous infusion as a total dose
intervention type: Biological
intervention name: P-BCMA-101 CAR-T cells
description: P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a "safety switch" gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort B)
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort C)
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)
arm group label: Phase 1: P-BCMA-101 CAR-T cells
arm group label: Phase 2: P-BCMA-101 CAR-T Cells
intervention type: Drug
intervention name: Rimiducid
description: Rimiducid (safety switch activator) may be administered as indicated.
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort B)
arm group label: Phase 1 P-BCMA-101 CAR-T cells (Cohort C)
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)
arm group label: Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)
arm group label: Phase 1: P-BCMA-101 CAR-T cells
arm group label: Phase 2: P-BCMA-101 CAR-T Cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rajesh Belani, M.D.
role: Study Director
affiliation: Sponsor Executive Medical Director
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 