xml: <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/NCT06014762</url>
    </required_header>
    <id_info>
      <org_study_id>P-CD19CD20-ALLO1-001</org_study_id>
      <nct_id>NCT06014762</nct_id>
    </id_info>
    <brief_title>P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies</brief_title>
    <official_title>Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Poseida Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Roche-Genentech</agency>
        <agency_class>Industry</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 study comprised of open-label, dose escalation and expansion cohort study of&#xD;
        P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with&#xD;
        relapsed/refractory B cell malignancies&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Phase 1 study consisting of two parts. Part 1 is a weight-based dose escalation following a&#xD;
        3+3 design of dose-escalating cohorts to determine a Recommended Phase 2 Dose (RP2D). Part 2&#xD;
        includes administration at a fixed dose. After enrollment, subjects may receive a&#xD;
        lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered&#xD;
        as a single dose. Treated subjects will undergo serial measurements of safety, tolerability&#xD;
        and response. Rimiducid may be administered as indicated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2041</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2029</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To assess the safety and MTD of P-CD19CD20-ALLO1 based on dose limiting toxicities (DLT)</measure>
      <time_frame>Baseline through 28 days</time_frame>
      <description>Number of subjects with DLT at each dose level to define an MTD</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The safety of P-CD19CD20-ALLO1 (AEs)</measure>
      <time_frame>Baseline through 36 months</time_frame>
      <description>Incidence and severity of adverse events (AEs)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The safety of P-CD19CD20-ALLO1 (CRS)</measure>
      <time_frame>Baseline through 36 months</time_frame>
      <description>o Cytokine release syndrome (CRS) graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (ORR)</measure>
      <time_frame>Baseline through 15 years</time_frame>
      <description>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>The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (DOR)</measure>
      <time_frame>Baseline through 15 years</time_frame>
      <description>Duration of Response - Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (PFS)</measure>
      <time_frame>Baseline through 15 years</time_frame>
      <description>Progression Free Survival (PFS) - Time from P-CD19CD20-ALLO1 treatment to progressive disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (OS)</measure>
      <time_frame>Baseline through 15 years</time_frame>
      <description>Overall Survival (OS) - Duration of survival from time of treatment with P-CD19CD20-ALLO1</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Diffuse Large B Cell Lymphoma</condition>
    <condition>Follicular Lymphoma</condition>
    <condition>Mantle Cell Lymphoma</condition>
    <condition>Marginal Zone Lymphoma</condition>
    <condition>Primary Mediastinal Large B-cell Lymphoma (PMBCL)</condition>
    <condition>Chronic Lymphocytic Leukemia</condition>
    <arm_group>
      <arm_group_label>P-CD19CD20-ALLO1 CAR-T Cells</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After 2 rest days following the lymphodepletion chemotherapy regimen, subjects will be treated with P-CD19CD20-ALLO1 administered IV on Day 0 (single administration).</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>P-CD19CD20-ALLO1</intervention_name>
      <description>Allogeneic chimeric antigen receptor T cells (CAR-T) targeting both CD19 and CD20</description>
      <arm_group_label>P-CD19CD20-ALLO1 CAR-T Cells</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rimiducid</intervention_name>
      <description>Safety switch activator</description>
      <arm_group_label>P-CD19CD20-ALLO1 CAR-T Cells</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Must have signed written, informed consent.&#xD;
  &#xD;
            2. Males or females ≥ 18 years of age.&#xD;
  &#xD;
            3. Must have prior biopsy proven confirmed diagnosis of DLBCL, FL, MCL, MZL, PMBCL, or&#xD;
               CLL.&#xD;
  &#xD;
            4. Diagnosis of one of the following:&#xD;
  &#xD;
                 1. DLBCL, FL, MCL, MZL, or PMBCL by World Health Organization (WHO) 2016 (Swerdlow,&#xD;
                    2016) criteria&#xD;
  &#xD;
                 2. CLL that meets published diagnostic criteria (Hallek, 2018):&#xD;
  &#xD;
               i. Monoclonal B cells (either kappa or lambda light chain restricted) that are&#xD;
               clonally co-expressing ≥ 1 B cell marker (CD19, CD20, or CD23) and CD5.&#xD;
  &#xD;
               ii. Prolymphocytes comprising ≤ 55% of blood lymphocytes. iii. Presence of ≥ 5 × 109 B&#xD;
               lymphocytes/L (5000/µL) in the peripheral blood (at any point since initial&#xD;
               diagnosis).&#xD;
  &#xD;
            5. CLL must be documented as CD20-positive.&#xD;
  &#xD;
            6. CLL must be documented as active disease meeting ≥ 1 of the following iwCLL 2018&#xD;
               criteria (Hallek, 2018) for requiring treatment:&#xD;
  &#xD;
                 1. Evidence of progressive marrow failure as manifested by the development of, or&#xD;
                    worsening of, anemia (hemoglobin &lt; 10 g/dL) and/or thrombocytopenia (platelets &lt;&#xD;
                    100,000/μL)&#xD;
  &#xD;
                 2. Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic&#xD;
                    splenomegaly.&#xD;
  &#xD;
                 3. Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or&#xD;
                    symptomatic lymphadenopathy.&#xD;
  &#xD;
                 4. Progressive lymphocytosis with an increase of &gt; 50% over a 2 month period or a&#xD;
                    lymphocyte doubling time (LDT) of &lt; 6 months. LDT may be obtained by linear&#xD;
                    regression extrapolation of absolute lymphocyte count (ALC) obtained at intervals&#xD;
                    of 2 weeks over an observation period of 2 to 3 months. In subjects with initial&#xD;
                    blood lymphocyte counts of &lt; 30 × 109/L (30,000/μL), LDT should not be used as a&#xD;
                    single parameter to define indication for treatment. In addition, factors&#xD;
                    contributing to lymphocytosis or lymphadenopathy other than CLL (e.g.,&#xD;
                    infections) should be excluded.&#xD;
  &#xD;
                 5. Constitutional symptoms documented in the subject's chart with supportive&#xD;
                    objective measures, as appropriate, defined as ≥ 1 of the following&#xD;
                    disease-related symptoms or signs:&#xD;
  &#xD;
               i. Unintentional weight loss ≥ 10% within the previous 6 months before Screening.&#xD;
  &#xD;
               ii. Significant fatigue (ECOG performance score 2; inability to work or perform usual&#xD;
               activities).&#xD;
  &#xD;
               iii. Fevers higher than 100.5°F or 38.0°C for ≥ 2 weeks before Screening without&#xD;
               evidence of infection.&#xD;
  &#xD;
               iv. Night sweats for &gt; 1 month before Screening without evidence of infection.&#xD;
  &#xD;
            7. DLBCL, FL, MCL, MZL, or PMBCL must have measurable disease as defined by Lugano 2016&#xD;
               criteria (Cheson, 2016).&#xD;
  &#xD;
            8. Must have relapsed/refractory disease as defined by the following:&#xD;
  &#xD;
                 1. DLBCL, FL, MCL, or PMBCL: received 2 lines of therapy that must include&#xD;
                    rituximab, cyclophosphamide, doxorubicin hydrochloride (i.e., hydroxydaunomycin),&#xD;
                    vincristine sulfate (i.e., oncovin), and prednisone (R-CHOP) or equivalent&#xD;
                    regimen and either autologous stem cell transplant (ASCT) or autologous CD19&#xD;
                    targeting CAR-T therapy, or not a candidate for ASCT or autologous CD19 targeting&#xD;
                    CAR-T.&#xD;
  &#xD;
                    OR&#xD;
  &#xD;
                 2. MZL: received 2 lines of therapy that must include a CD20 monoclonal antibody&#xD;
                    (mAb) and a Bruton tyrosine kinase inhibitor (BTKi) OR&#xD;
  &#xD;
                 3. CLL: received 2 lines of therapy that must include a CD20 mAb and a BTKi&#xD;
  &#xD;
            9. Must be willing to practice birth control from the time of Screening and throughout&#xD;
               the first year of the study after P-CD19CD20-ALLO1 administration (both males and&#xD;
               females of childbearing potential).&#xD;
  &#xD;
           10. Must have a negative serum pregnancy test at Screening and a negative urine pregnancy&#xD;
               test within 3 days prior to initiating the lymphodepletion chemotherapy regimen&#xD;
               (females of childbearing potential).&#xD;
  &#xD;
           11. Must be at least 90 days since ASCT, if performed.&#xD;
  &#xD;
           12. Must be at least 4 weeks since autologous CAR-T therapy if such therapy was&#xD;
               administered (medical monitor must approve prior CAR T therapy or other prior T cell&#xD;
               targeted therapy).&#xD;
  &#xD;
           13. Must have adequate vital organ function, defined as follows (or medical monitor&#xD;
               approval):&#xD;
  &#xD;
                 1. Serum creatinine ≤ 1.5 mg/dL or estimated creatinine clearance&#xD;
  &#xD;
                    ≥ 30 mL/min as calculated using the Cockcroft Gault formula and not&#xD;
                    dialysis-dependent.&#xD;
  &#xD;
                 2. Adequate hematologic function, including:&#xD;
  &#xD;
               i. Absolute neutrophil count (ANC) ≥ 1000/μL in the absence of growth factor support&#xD;
               (granulocyte-colony stimulating factor [G-CSF] within 7 days or peg-G-CSF within 14&#xD;
               days) ii. Platelet count ≥ 50,000/μL in the absence of transfusion support (platelet&#xD;
               transfusion within 7 days) iii. Hemoglobin ≥ 8 g/dL in the absence of transfusion&#xD;
               support (red blood cell count or whole blood within 7 days) c. Aspartate transaminase&#xD;
               (AST) and alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN), and&#xD;
               total bilirubin ≤ 2.0 mg/dL (unless there is a history of Gilbert's Syndrome in which&#xD;
               case bilirubin levels ≤ 3 mg/dL).&#xD;
  &#xD;
               d. Left ventricular ejection fraction (LVEF) ≥ 45%. LVEF assessment must have been&#xD;
               performed within 4 weeks of enrollment.&#xD;
  &#xD;
           14. Must have recovered from toxicities due to prior therapies to Grade ≤ 2 according to&#xD;
               the NCI CTCAE v5.0 criteria or to the subject's prior baseline.&#xD;
  &#xD;
           15. Must have an ECOG performance status of 0 to 2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Is pregnant or lactating.&#xD;
  &#xD;
            2. Has inadequate venous access.&#xD;
  &#xD;
            3. Has active hemolytic anemia, POEMS syndrome (polyneuropathy, organomegaly,&#xD;
               endocrinopathy, monoclonal protein, and skin changes), disseminated intravascular&#xD;
               coagulation, leukostasis, or amyloidosis.&#xD;
  &#xD;
            4. Has an active second malignancy (not disease-free for at least 5 years) in addition to&#xD;
               non-Hodgkin lymphoma or CLL, excluding low-risk neoplasms such as non-metastatic basal&#xD;
               cell or squamous cell skin carcinoma.&#xD;
  &#xD;
            5. Has active autoimmune disease, such as psoriasis, multiple sclerosis, lupus,&#xD;
               rheumatoid arthritis, etc. (the medical monitor will determine if a disease is active&#xD;
               and autoimmune).&#xD;
  &#xD;
            6. Has a history of significant central nervous system (CNS) disease, such as stroke,&#xD;
               epilepsy, primary CNS lymphoma, etc. (the medical monitor will determine if&#xD;
               significant).&#xD;
  &#xD;
            7. Has an active systemic infection (e.g., causing fevers or requiring antimicrobial&#xD;
               treatment).&#xD;
  &#xD;
            8. Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human&#xD;
               immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any&#xD;
               immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be&#xD;
               enrolled if negative by hepatitis C polymerase chain reaction (PCR) on multiple&#xD;
               occasions and with medical monitor approval.&#xD;
  &#xD;
            9. Is positive for human herpes virus (HHV)-6 or HHV-7 infection by polymerase chain&#xD;
               reaction (PCR) at the Screening Visit (subjects may be included in the study if they&#xD;
               are HHV-6 or HHV-7 antibody-positive but PCR-negative).&#xD;
  &#xD;
           10. Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina,&#xD;
               or a history of myocardial infarction or significant arrhythmia (e.g., atrial&#xD;
               fibrillation, sustained [&gt; 30 seconds] ventricular tachyarrhythmias, etc.).&#xD;
  &#xD;
           11. Has any psychiatric or medical disorder (e.g., cardiovascular, endocrine, renal,&#xD;
               gastrointestinal, genitourinary, immunodeficiency or pulmonary disorder not otherwise&#xD;
               specified) that would, in the opinion of the Investigator or medical monitor, preclude&#xD;
               safe participation in and/or adherence to the protocol (including medical conditions&#xD;
               or laboratory findings that indicate a significant probability of not qualifying for&#xD;
               or being unable to undergo, conditioning chemotherapy and/or CAR-T cell&#xD;
               administration).&#xD;
  &#xD;
           12. Has received non-mAb anti-cancer medications within 2 weeks of the time of initiating&#xD;
               conditioning chemotherapy.&#xD;
  &#xD;
           13. Has received mAb therapy within 4 weeks of initiating conditioning chemotherapy.&#xD;
  &#xD;
           14. Has received immunosuppressive medications within 2 weeks of the time of&#xD;
               administration of P-CD19CD20-ALLO1, and/or expected to require them while on study&#xD;
               (the medical monitor will determine if a medication is considered immunosuppressive).&#xD;
  &#xD;
           15. Has received systemic corticosteroid therapy ≥ 5 mg/day of prednisone or equivalent&#xD;
               dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) of&#xD;
               the administration of P-CD19CD20-ALLO1 or is expected to require it during the course&#xD;
               of the study. (Topical and inhaled steroids are permitted. Systemic corticosteroids&#xD;
               are contraindicated after receiving P-CD19CD20-ALLO1 cells outside of study-specific&#xD;
               guidance).&#xD;
  &#xD;
           16. Has CNS metastases or symptomatic CNS involvement (including leptomeningeal&#xD;
               carcinomatosis, cranial neuropathies or mass lesions and spinal cord compression).&#xD;
  &#xD;
           17. Has a history of severe immediate hypersensitivity reaction to any of the agents used&#xD;
               in this study.&#xD;
  &#xD;
           18. Has a history of having undergone allogeneic or xenogeneic transplant, or has&#xD;
               undergone autologous transplantation within 90 days.&#xD;
  &#xD;
           19. Has received prior allogeneic cellular therapy.&#xD;
  &#xD;
           20. History or Grade ≥ 3 HLH/MAS or neurotoxicity with prior therapies (all symptoms of&#xD;
               HLH/MAS, neurotoxicity, or CRS from prior therapies must be resolved at the time of&#xD;
               enrollment).&#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, MD</last_name>
      <role>Study Director</role>
      <affiliation>Vice President, Clinical Development</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Angie Schinkel</last_name>
      <phone>858-779-3103</phone>
      <email>clinicaltrials@poseida.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California San Diego</name>
        <address>
          <city>La Jolla</city>
          <state>California</state>
          <zip>92093</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>UNC Lineberger Comprehensive Cancer Center</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Cincinnati</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45206</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Oklahoma, Health Sciences Center</name>
        <address>
          <city>Oklahoma City</city>
          <state>Oklahoma</state>
          <zip>73104</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Prisma Health - Upstate Cancer Institute</name>
        <address>
          <city>Greenville</city>
          <state>South Carolina</state>
          <zip>29605</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>Baylor Scott &amp; White Research Institute</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75204</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, B-Cell</mesh_term>
      <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
      <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
      <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014762
  org study id: P-CD19CD20-ALLO1-001
  nct id: NCT06014762
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Phase 1 study comprised of open-label, dose escalation and expansion cohort study of
        P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with
        relapsed/refractory B cell malignancies
  Phase 1 study consisting of two parts. Part 1 is a weight-based dose escalation following a
        3+3 design of dose-escalating cohorts to determine a Recommended Phase 2 Dose (RP2D). Part 2
        includes administration at a fixed dose. After enrollment, subjects may receive a
        lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered
        as a single dose. Treated subjects will undergo serial measurements of safety, tolerability
        and response. Rimiducid may be administered as indicated.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To assess the safety and MTD of P-CD19CD20-ALLO1 based on dose limiting toxicities (DLT)
  time frame: Baseline through 28 days
  description: Number of subjects with DLT at each dose level to define an MTD
  measure: The safety of P-CD19CD20-ALLO1 (AEs)
  time frame: Baseline through 36 months
  description: Incidence and severity of adverse events (AEs)
  measure: The safety of P-CD19CD20-ALLO1 (CRS)
  time frame: Baseline through 36 months
  description: o Cytokine release syndrome (CRS) graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria
  measure: The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (ORR)
  time frame: Baseline through 15 years
  description: Overall Response Rate (ORR) - Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR)
  measure: The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (DOR)
  time frame: Baseline through 15 years
  description: Duration of Response - Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease
  measure: The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (PFS)
  time frame: Baseline through 15 years
  description: Progression Free Survival (PFS) - Time from P-CD19CD20-ALLO1 treatment to progressive disease
  measure: The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (OS)
  time frame: Baseline through 15 years
  description: Overall Survival (OS) - Duration of survival from time of treatment with P-CD19CD20-ALLO1
  arm group label: P-CD19CD20-ALLO1 CAR-T Cells
  arm group type: Experimental
  description: After 2 rest days following the lymphodepletion chemotherapy regimen, subjects will be treated with P-CD19CD20-ALLO1 administered IV on Day 0 (single administration).
  intervention type: Biological
  intervention name: P-CD19CD20-ALLO1
  description: Allogeneic chimeric antigen receptor T cells (CAR-T) targeting both CD19 and CD20
  arm group label: P-CD19CD20-ALLO1 CAR-T Cells
  intervention type: Drug
  intervention name: Rimiducid
  description: Safety switch activator
  arm group label: P-CD19CD20-ALLO1 CAR-T Cells
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rajesh Belani, MD
  role: Study Director
  affiliation: Vice President, Clinical Development
  last name: Angie Schinkel
  phone: 858-779-3103
  email: clinicaltrials@poseida.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
  mesh term: Lymphoma, Mantle-Cell
  mesh term: Lymphoma, Large B-Cell, Diffuse