<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/NCT04447573</url>
  </required_header>
  <id_info>
    <org_study_id>BCMA CAR-T</org_study_id>
    <nct_id>NCT04447573</nct_id>
  </id_info>
  <brief_title>Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma</brief_title>
  <official_title>Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Senlang Biotechnology Inc., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Lu Daopei Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Yanda Ludaopei Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hebei Senlang Biotechnology Inc., Ltd.</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 study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the&#xD;
      treatment of relapsed or refractory multiple myeloma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the&#xD;
      treatment of relapsed or refractory multiple myeloma.&#xD;
&#xD;
      The Main research objectives:&#xD;
&#xD;
      To evaluate the safety and efficacy of BCMA CAR-T in patients with relapsed or refractory&#xD;
      multiple myeloma&#xD;
&#xD;
      The Secondary research objectives:&#xD;
&#xD;
      To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or&#xD;
      refractory multiple myeloma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</primary_completion_date>
  <phase>N/A</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: Incidence and severity of adverse events</measure>
    <time_frame>First month post CAR-T cells infusion</time_frame>
    <description>To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy: Overall Remission Rate (ORR)</measure>
    <time_frame>3 months post CAR-T cells infusion</time_frame>
    <description>Overall Remission Rate (ORR) including partial remission and complete</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy:duration of response (DOR)</measure>
    <time_frame>24 months post CAR-T cells infusion</time_frame>
    <description>duration of response (DOR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: progression-free survival (PFS)</measure>
    <time_frame>24 months post CAR-T cells infusion</time_frame>
    <description>progression-free survival (PFS) time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CAR-T proliferation</measure>
    <time_frame>3 months post CAR-T cells infusion</time_frame>
    <description>the copy number of BCMA CAR- T cells in the genomes of PBMC by qPCR method and percentage of BCMA CAR- T cells measured by flow cytometry method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine release</measure>
    <time_frame>First month post CAR-T cells infusion</time_frame>
    <description>Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>BCMA CAR-T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with BCMA CAR-T cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BCMA CAR-T</intervention_name>
    <description>Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;</description>
    <arm_group_label>BCMA CAR-T cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subjects voluntarily participated in the study and signed the informed consent&#xD;
             form by themselves or their legal guardian;&#xD;
&#xD;
          2. According to the international standard for multiple myeloma (IMWG 2014);&#xD;
&#xD;
          3. Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were&#xD;
             defined as follow. Relapsed: patients had received for at least 3 drugs with different&#xD;
             mechanisms of action (including protease inhibitors and immunomodulators) and disease&#xD;
             progression within 60 days of the most recent treatment. Refractory was defined as:&#xD;
             disease progression occurred during the recent treatment, or disease progression&#xD;
             occurred within 60 days after treatment;&#xD;
&#xD;
          4. The expression of BCMA in myeloma cells was reported as positive by flow cytometry or&#xD;
             immunohistochemistry;&#xD;
&#xD;
          5. No antibody drug was administered within last 2 weeks before cell therapy;&#xD;
&#xD;
          6. ECOG Scores: 0~1&#xD;
&#xD;
          7. Echocardiography showed normal diastolic function, left ventricular ejection fraction&#xD;
             (LVEF) ≥ 50%, no serious arrhythmia;&#xD;
&#xD;
          8. The subjects had no pulmonary infection, normal pulmonary function, and indoor air&#xD;
             oxygen saturation ≥ 92%;&#xD;
&#xD;
          9. There was no contraindication for peripheral blood sampling;&#xD;
&#xD;
         10. The estimated survival time was more than 12 weeks;&#xD;
&#xD;
         11. The urine pregnancy test of female subjects of childbearing age should be negative and&#xD;
             not in lactation; the female or male subjects of childbearing age should take&#xD;
             effective contraceptive measures during the whole research process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a history of allergy to any component of cell products;&#xD;
&#xD;
          2. There are clinically significant cardiovascular diseases, such as uncontrolled or&#xD;
             symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade&#xD;
             4 (severe) heart disease with cardiac function (according to the functional&#xD;
             classification method of the New York Heart AssociationNYHA) with a history of&#xD;
             myocardial infarction, angioplasty or stent implantation, unstable angina or other&#xD;
             clinically significant heart disease within 12 months before admission;&#xD;
&#xD;
          3. who has suffered from brain injury, consciousness disorder, epilepsy, more serious&#xD;
             cerebral ischemia or cerebral hemorrhage disease;&#xD;
&#xD;
          4. Patients who need urgent treatment due to tumor progression or spinal cord&#xD;
             compression;&#xD;
&#xD;
          5. The investigator determines that there are serious complications or diseases that will&#xD;
             increase the risk of the subject or affect the study, including but not limited to,&#xD;
             for example, cirrhosis, recent major trauma, etc;&#xD;
&#xD;
          6. After allogeneic hematopoietic stem cell transplantation;&#xD;
&#xD;
          7. Patients with autoimmune diseases, immunodeficiency or other diseases requiring&#xD;
             immunosuppressive （excluding glucocorticoid）therapy;&#xD;
&#xD;
          8. There was uncontrolled active infection;&#xD;
&#xD;
          9. There were live vaccinations within 4 weeks before admission;&#xD;
&#xD;
         10. Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and&#xD;
             congenital immunodeficiency diseases, including but not limited to those with HIV&#xD;
             infection;&#xD;
&#xD;
         11. Subjects had a history of alcohol, drug or mental illness;&#xD;
&#xD;
         12. The researchers believe that there are other conditions that subjects are not suitable&#xD;
             to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peihua Lu, PhD&amp;MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Lu Daopei Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peihua Lu, PhD&amp;MD</last_name>
    <phone>008618611636172</phone>
    <email>peihua_lu@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jianqiang Li, PhD&amp;MD</last_name>
    <phone>008615511369555</phone>
    <email>limmune@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>He bei Yan da Lu dao pei Hospital</name>
      <address>
        <city>Yanda</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peihua Lu, MD/PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>BeiJing Ludaopei Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Yizhuang</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peihua Lu, PhD&amp;MD</last_name>
      <phone>008618611636172</phone>
      <email>peihua_lu@126.com</email>
    </contact>
    <investigator>
      <last_name>Peihua Lu, PhD&amp;MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jianqiang Li, PhD&amp;MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BCMA，MM</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>
  <!-- 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/NCT04447573
org study id: BCMA CAR-T
nct id: NCT04447573
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the
      treatment of relapsed or refractory multiple myeloma
This is a study to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the
      treatment of relapsed or refractory multiple myeloma.

      The Main research objectives:

      To evaluate the safety and efficacy of BCMA CAR-T in patients with relapsed or refractory
      multiple myeloma

      The Secondary research objectives:

      To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or
      refractory multiple myeloma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety: Incidence and severity of adverse events
time frame: First month post CAR-T cells infusion
description: To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
measure: Efficacy: Overall Remission Rate (ORR)
time frame: 3 months post CAR-T cells infusion
description: Overall Remission Rate (ORR) including partial remission and complete
measure: Efficacy:duration of response (DOR)
time frame: 24 months post CAR-T cells infusion
description: duration of response (DOR)
measure: Efficacy: progression-free survival (PFS)
time frame: 24 months post CAR-T cells infusion
description: progression-free survival (PFS) time
measure: CAR-T proliferation
time frame: 3 months post CAR-T cells infusion
description: the copy number of BCMA CAR- T cells in the genomes of PBMC by qPCR method and percentage of BCMA CAR- T cells measured by flow cytometry method
measure: Cytokine release
time frame: First month post CAR-T cells infusion
description: Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
arm group label: BCMA CAR-T cells
arm group type: Experimental
description: Patients will be treated with BCMA CAR-T cells
intervention type: Biological
intervention name: BCMA CAR-T
description: Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
arm group label: BCMA CAR-T cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Peihua Lu, PhD&MD
role: Principal Investigator
affiliation: Beijing Lu Daopei Hospital
last name: Peihua Lu, PhD&MD
phone: 008618611636172
email: peihua_lu@126.com
last name: Jianqiang Li, PhD&MD
phone: 008615511369555
email: limmune@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell