<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/NCT03752541</url>
  </required_header>
  <id_info>
    <org_study_id>2018-CAR-00CH3</org_study_id>
    <nct_id>NCT03752541</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Evaluation of BCMA-UCART</brief_title>
  <official_title>Efficacy and Safety Evaluation of BCMA-UCART（Allogeneic Engineered T-cells Expressing Anti-BCMA Chimeric Antigen Receptor）in the Treatment of Relapsed or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioray Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bioray Laboratories</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 trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with&#xD;
      relapsed or refractory multiple myeloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma. Using a genetic&#xD;
      engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in T cells will&#xD;
      help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a&#xD;
      kind of allogeneic CART, originating from T cells of health donors. This open-label,&#xD;
      dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in&#xD;
      treating relapsed or refractory multiple myeloma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    decided by the sponsor&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">November 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 20, 2023</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>Sequential Assignment</intervention_model>
    <intervention_model_description>0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to 90 days after T cell infusion</time_frame>
    <description>Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 35 days after T cell infusion</time_frame>
    <description>Adverse events assessed according to NCI-CTCAE v4.03 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of persistence of BCMA-UCART</measure>
    <time_frame>Baseline up to 1 year</time_frame>
    <description>Detect the duration of BCMA-UCART after injection using FACS or Q-PCR</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-UCART</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BCMA-UCART</intervention_name>
    <description>A conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy.</description>
    <arm_group_label>BCMA-UCART</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have the capacity to give informed consent;&#xD;
&#xD;
          -  Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;&#xD;
&#xD;
          -  Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by&#xD;
             flow cytometry obtained within 45 days of study enrollment);&#xD;
&#xD;
          -  Refractory and relapsed MM patients after &gt; 2 cycles of induction therapy,or,have&#xD;
             relapsed or treatment refractory disease following autologous stem cell transplant&#xD;
             (ASCT);&#xD;
&#xD;
          -  ECOG score=0-2.&#xD;
&#xD;
          -  Subjects according with any of the following options:&#xD;
&#xD;
               -  Age≥50;&#xD;
&#xD;
               -  Failure with separation of T cells during autologous CART processing; or,&#xD;
&#xD;
               -  Failure with expansion of autologous CART; or,&#xD;
&#xD;
               -  The proportion of T cells in PBMC &lt;10%; or,&#xD;
&#xD;
               -  Won't benefit from autologous CART therapy because of disease progress.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women; Women of reproductive potential must have a negative serum&#xD;
             pregnancy test performed within 48 hours of starting conditioning chemotherapy&#xD;
&#xD;
          -  Active infection, HIV infection, syphilis serology reaction positive;&#xD;
&#xD;
          -  Active hepatitis B, hepatitis C at the time of screening&#xD;
&#xD;
          -  Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic&#xD;
             transaminase)&gt; 5 x upper limit of normal; bilirubin &gt; 3.0 mg/dL;&#xD;
&#xD;
          -  Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis&#xD;
&#xD;
          -  serious mental disorder;&#xD;
&#xD;
          -  With severe cardiac, liver, renal insufficiency, diabetes and other diseases;&#xD;
&#xD;
          -  Participate in other clinical research in the past three months; previously treatment&#xD;
             with any gene therapy products&#xD;
&#xD;
          -  Contraindication to cyclophosphamide or fludarabine chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aibin Liang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Tongji Hospital, Tongji University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>May 15, 2022</last_update_submitted>
  <last_update_submitted_qc>May 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03752541
org study id: 2018-CAR-00CH3
nct id: NCT03752541
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with
      relapsed or refractory multiple myeloma.
BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma. Using a genetic
      engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in T cells will
      help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a
      kind of allogeneic CART, originating from T cells of health donors. This open-label,
      dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in
      treating relapsed or refractory multiple myeloma.
allocation: N/A
intervention model: Sequential Assignment
intervention model description: 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: Up to 90 days after T cell infusion
description: Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
measure: Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
time frame: Up to 35 days after T cell infusion
description: Adverse events assessed according to NCI-CTCAE v4.03 criteria
measure: Duration of persistence of BCMA-UCART
time frame: Baseline up to 1 year
description: Detect the duration of BCMA-UCART after injection using FACS or Q-PCR
arm group label: BCMA-UCART
arm group type: Experimental
description: Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW.
intervention type: Biological
intervention name: BCMA-UCART
description: A conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy.
arm group label: BCMA-UCART
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aibin Liang, PhD
role: Principal Investigator
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: No