<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/NCT03271632</url>
  </required_header>
  <id_info>
    <org_study_id>GIMI-IRB-17013</org_study_id>
    <nct_id>NCT03271632</nct_id>
  </id_info>
  <brief_title>Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma</brief_title>
  <official_title>Multiple Antigen-specific CAR T Cells For the Treatment of Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen Geno-Immune Medical Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenzhen Geno-Immune Medical Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this clinical trial is to assess the feasibility, safety and efficacy of&#xD;
      autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in&#xD;
      relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more&#xD;
      about the persistence and function of CAR T cells in the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple myeloma (MM) is a malignancy of plasma cells, which remains a clinical challenge&#xD;
      despite advanced therapeutic interventions including novel molecular therapies and stem cell&#xD;
      transplantation (SCT). This trial is to test the safety and efficacy of T cells genetically&#xD;
      modified to specifically target several MM surface antigens, including BCMA, CD38, CD56,&#xD;
      CD138 or alternative MM surface antigens, based on a multi-CAR T cell immunotherapy approach.&#xD;
      Another goal of the study is to investigate the persistence and function of CAR T cells in&#xD;
      the body after CAR T cell infusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 15, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>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>Percentage of patients with treatment related adverse effect</measure>
    <time_frame>1 month</time_frame>
    <description>percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity of fourth generation multiple CAR-T cells after infusion</measure>
    <time_frame>1 year</time_frame>
    <description>by measuring CAR copies in the body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM</measure>
    <time_frame>1 year</time_frame>
    <description>by physical examination of tumor burden</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CAR T cells to treat MM</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CAR T cells</intervention_name>
    <description>Infusion of multi-CAR T cells</description>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects with surface antigen confirmed multiple myeloma with no&#xD;
             available curative treatment options (including autologous or allogeneic SCT).&#xD;
&#xD;
          -  Complete remission (CR) cannot be achieved after at least 4 prior combination therapy&#xD;
             regimens.&#xD;
&#xD;
          -  MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid&#xD;
             diseases, or lack of available donor.&#xD;
&#xD;
          -  Less than 1 year between last chemotherapy and progression (i.e. most recent&#xD;
             progression free interval &lt; 1 year).&#xD;
&#xD;
          -  Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual&#xD;
             disease after at least 1 prior therapy and not eligible for allogeneic SCT.&#xD;
&#xD;
          -  Residual disease after primary therapy and not eligible for ASCT&#xD;
&#xD;
          -  Expected survival &gt; 12 weeks&#xD;
&#xD;
          -  Creatinine &lt; 2.5 mg/dl&#xD;
&#xD;
          -  ALT (alanine aminotransferase)/AST (aspartate aminotransferase) &lt; 3x normal&#xD;
&#xD;
          -  Bilirubin &lt; 2.0 mg/dl&#xD;
&#xD;
          -  Any relapse after prior SCT is eligible regardless of other prior therapy&#xD;
&#xD;
          -  Adequate venous access for apheresis, and no other contraindications for leukapheresis&#xD;
&#xD;
          -  Voluntary informed consent is given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Uncontrolled active infection&#xD;
&#xD;
          -  Active hepatitis B or hepatitis C infection&#xD;
&#xD;
          -  Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not&#xD;
             exclusionary.&#xD;
&#xD;
          -  Previous related CAR-T cell therapy Any uncontrolled active medical disorder that&#xD;
             would preclude participation&#xD;
&#xD;
          -  HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lung-Ji Chang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shenzhen Geno-Immune Medical Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lung-Ji Chang</last_name>
    <phone>86-075586725195</phone>
    <email>c@szgimi.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shenzhen Geno-immune Medical Institute</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lung-Ji Chang, PhD</last_name>
      <phone>86-075586725195</phone>
      <email>c@szgimi.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Yunnan</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xun Lai, Master</last_name>
      <phone>13577096609</phone>
      <email>1729112214@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenzhen Geno-Immune Medical Institute</investigator_affiliation>
    <investigator_full_name>Lung-Ji Chang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>multiple myeloma</keyword>
  <keyword>chimeric antigen receptor</keyword>
  <keyword>BCMA</keyword>
  <keyword>CD38</keyword>
  <keyword>CD56</keyword>
  <keyword>CD138</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>
  <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/NCT03271632
org study id: GIMI-IRB-17013
nct id: NCT03271632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this clinical trial is to assess the feasibility, safety and efficacy of
      autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in
      relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more
      about the persistence and function of CAR T cells in the body.
Multiple myeloma (MM) is a malignancy of plasma cells, which remains a clinical challenge
      despite advanced therapeutic interventions including novel molecular therapies and stem cell
      transplantation (SCT). This trial is to test the safety and efficacy of T cells genetically
      modified to specifically target several MM surface antigens, including BCMA, CD38, CD56,
      CD138 or alternative MM surface antigens, based on a multi-CAR T cell immunotherapy approach.
      Another goal of the study is to investigate the persistence and function of CAR T cells in
      the body after CAR T cell infusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients with treatment related adverse effect
time frame: 1 month
description: percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.
measure: Anti-tumor activity of fourth generation multiple CAR-T cells after infusion
time frame: 1 year
description: by measuring CAR copies in the body
measure: Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM
time frame: 1 year
description: by physical examination of tumor burden
arm group label: Single arm
arm group type: Experimental
description: CAR T cells to treat MM
intervention type: Biological
intervention name: CAR T cells
description: Infusion of multi-CAR T cells
arm group label: Single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lung-Ji Chang
role: Principal Investigator
affiliation: Shenzhen Geno-Immune Medical Institute
last name: Lung-Ji Chang
phone: 86-075586725195
email: c@szgimi.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shenzhen Geno-Immune Medical Institute
investigator full name: Lung-Ji Chang
investigator title: Principal Investigator
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: No