<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/NCT03815383</url>
  </required_header>
  <id_info>
    <org_study_id>0203-008</org_study_id>
    <nct_id>NCT03815383</nct_id>
  </id_info>
  <brief_title>A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma</brief_title>
  <official_title>A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, non-randomized and dose-escalation study to evaluate the safety and&#xD;
      efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include the following sequential phases: Screening, Pre- Treatment (Cell&#xD;
      Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Safety:TEAEs</measure>
    <time_frame>30 days</time_frame>
    <description>The incidence of treatment-emergent adverse events (TEAEs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>12 months</time_frame>
    <description>Overall response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>6 months, 12 months</time_frame>
    <description>Progression free survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Relapsed or Refractory Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>C-CAR088</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>C-CAR088</intervention_name>
    <description>Autologous BCMA-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.</description>
    <arm_group_label>C-CAR088</arm_group_label>
    <other_name>CBM.BCMA Chimeric Antigen Receptor T cell</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Volunteered to participate in this study and signed informed consent.&#xD;
&#xD;
          2. Age 18-75 years old, male or female.&#xD;
&#xD;
          3. Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG&#xD;
             diagnostic criteria 2014).&#xD;
&#xD;
          4. Patients with relapsed or refractory multiple myeloma.&#xD;
&#xD;
          5. Subjects have one or more measurable multiple myeloma lesion, must include one of the&#xD;
             following conditions:&#xD;
&#xD;
               -  Serum M protein≥1 g/dl(10g/L)&#xD;
&#xD;
               -  Urine M protein≥200 mg/24h&#xD;
&#xD;
               -  Serum free light chain(sFLC): κ/λ ratio abnormal and ≥10 mg/dl&#xD;
&#xD;
          6. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological&#xD;
             examination.&#xD;
&#xD;
          7. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.&#xD;
&#xD;
          8. ECOG scores 0 - 1.&#xD;
&#xD;
          9. Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50%&#xD;
             (detected by echocardiography), no serious arrhythmia.&#xD;
&#xD;
         10. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92%&#xD;
             on room air.&#xD;
&#xD;
         11. No contraindications of leukapheresis.&#xD;
&#xD;
         12. Expected survival &gt; 12 weeks.&#xD;
&#xD;
         13. Female subjects in childbearing age, their serum or urine pregnancy test must be&#xD;
             negative,until 7 days before cell therapy and all subjects must agree to take&#xD;
             effective contraceptive measures during the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a history of allergy to cellular products.&#xD;
&#xD;
          2. Any kind of these laboratory testing: including but not limited to,serum total&#xD;
             bilirubin≧1.5mg/dl, serum ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, Hb&#xD;
             (hemoglobin)&lt;80g/L, neutrophils&lt;1000/mm^3, platelets≦50000/mm^3 or platelet count&#xD;
             maintained by transfusion.&#xD;
&#xD;
          3. Subjects with the clinically significant cardiovascular diseases.&#xD;
&#xD;
          4. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral&#xD;
             ischemia or hemorrhagic disease.&#xD;
&#xD;
          5. Use any anticoagulant (except aspirin).&#xD;
&#xD;
          6. Patients requiring urgent treatment due to tumor progression or spinal cord&#xD;
             compression.&#xD;
&#xD;
          7. Patients with active CNS involvement or clinical syndrome of MM meningeal involvement.&#xD;
&#xD;
          8. After allogeneic hematopoietic stem cell transplantation.&#xD;
&#xD;
          9. Plasma cell leukemia.&#xD;
&#xD;
         10. Subjects with any autoimmune disease or any immune deficiency disease or other disease&#xD;
             in need of immunosuppressive therapy.&#xD;
&#xD;
         11. Uncontrolled active infection.&#xD;
&#xD;
         12. Prior treatment with CAR T therapy or any other genetically modified T cell therapy.&#xD;
&#xD;
         13. Live vaccine inoculation within four weeks before enrollment.&#xD;
&#xD;
         14. Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as&#xD;
             acquired, congenital immune deficiency diseases, including but not limited to&#xD;
             HIV-infected persons.&#xD;
&#xD;
         15. Have a history of alcoholism, drug addiction and mental illness.&#xD;
&#xD;
         16. Participated in any other clinical trial within one month.&#xD;
&#xD;
         17. The investigators believe that there are other circumstances that are not suitable for&#xD;
             the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianyong Li, PhD</last_name>
    <phone>025-83718836,83714511</phone>
    <email>lijianyonglm@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianyong Li, PhD</last_name>
      <email>lijianyonglm@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</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>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03815383
org study id: 0203-008
nct id: NCT03815383
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and
      efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell
      Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety:TEAEs
time frame: 30 days
description: The incidence of treatment-emergent adverse events (TEAEs)
measure: ORR
time frame: 12 months
description: Overall response rate
measure: PFS
time frame: 6 months, 12 months
description: Progression free survival
arm group label: C-CAR088
arm group type: Experimental
description: Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene
intervention type: Biological
intervention name: C-CAR088
description: Autologous BCMA-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.
arm group label: C-CAR088
other name: CBM.BCMA Chimeric Antigen Receptor T cell
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianyong Li, PhD
phone: 025-83718836,83714511
email: lijianyonglm@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell