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/NCT06006741</url>
    </required_header>
    <id_info>
      <org_study_id>GIMI-IRB-23003</org_study_id>
      <nct_id>NCT06006741</nct_id>
    </id_info>
    <brief_title>Universal CAR-T Cells Targeting Multiple Myeloma</brief_title>
    <official_title>Universal 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>
      <collaborator>
        <agency>The Second Affiliated Hospital of Hainan Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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 study is to assess the feasibility, safety and efficacy of universal CAR T&#xD;
        cells targeting multiple myeloma. Another goal of the study is to learn more about the&#xD;
        persistence and function of the universal CAR T cells in the body.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge&#xD;
        despite advanced therapeutic interventions including novel molecular therapies and stem cell&#xD;
        transplantation (SCT).&#xD;
  &#xD;
        CAR-T therapy has proven to be a revolutionary treatment for hematological malignancies, but&#xD;
        its manufacture is still limited by the high cost, and a long preparation time that is not&#xD;
        conducive to timely treatment of patients. In addition, many MM patients suffer from&#xD;
        long-term bone marrow suppression caused by tumor growth or prolonged and intense&#xD;
        chemotherapies, resulting in exhaustion, aging and functional defects of autologous T cells,&#xD;
        which substantially affect the quality of CAR-T cells and the clinical efficacy. The&#xD;
        universal CAR-T cells could overcome many of the above problems.&#xD;
  &#xD;
        By using universal type of CAR-T cells, the product can be supplied off-the-shelf without&#xD;
        being customized from individual patients. In addition, the immediate availability means that&#xD;
        patients under severe bone marrow suppression may get a chance to be treated with CAR-T cells&#xD;
        to achieve disease remission. In addition, those patients who suffer from long-term&#xD;
        immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have&#xD;
        the option of treatment with the universal CAR-T cells.&#xD;
  &#xD;
        The purpose of this study is to assess the feasibility, safety and efficacy of several 4SCAR&#xD;
        designs including BCMA, CD138, CD38 and CD19-specific universal CAR-T products targeting MM.&#xD;
        Another goal is to learn more about the function of these universal CAR T cells and their&#xD;
        persistency in the patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</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>Percentage of patients with treatment related adverse effect</measure>
      <time_frame>6 months</time_frame>
      <description>percentage of participants with treatment-related adverse events, as assessed by physical examination, vital signs, standard clinical lab tests.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anti-tumor activity of the universal 4SCAR-T cells after infusion</measure>
      <time_frame>3 months</time_frame>
      <description>CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM</measure>
      <time_frame>1 year</time_frame>
      <description>Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Multiple Myeloma in Remission</condition>
    <arm_group>
      <arm_group_label>Universal CART cells to treat MM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>MM-specific universal CAR T cells</intervention_name>
      <description>Infusion of MM-specific universal CAR T cells</description>
      <arm_group_label>Universal CART cells to treat MM</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with confirmed multiple myeloma failed curative treatment options (including&#xD;
               autologous or allogeneic SCT).&#xD;
  &#xD;
            2. Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.&#xD;
  &#xD;
            3. High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid&#xD;
               diseases.&#xD;
  &#xD;
            4. Less than 1 year between last chemotherapy and progression (i.e. most recent&#xD;
               progression free interval &lt; 1 year).&#xD;
  &#xD;
            5. Relapsed after prior autologous or allogenic SCT with residual disease after at least&#xD;
               1 prior therapy and not eligible for allogeneic SCT.&#xD;
  &#xD;
            6. Residual disease after primary therapy and not eligible for ASCT&#xD;
  &#xD;
            7. Expected survival &gt; 12 weeks• Creatinine &lt; 2.5 mg/dl• ALT (alanine&#xD;
               aminotransferase)/AST (aspartate aminotransferase) &lt; 3x normal&#xD;
  &#xD;
            8. Bilirubin &lt; 2.0 mg/dl&#xD;
  &#xD;
            9. Any relapse after prior SCT is eligible regardless of other prior therapy&#xD;
  &#xD;
           10. Adequate venous access for apheresis, and no other contraindications for leukapheresis&#xD;
  &#xD;
           11. Voluntary informed consent is signed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or lactating women&#xD;
  &#xD;
            2. Uncontrolled active infection&#xD;
  &#xD;
            3. Active hepatitis B or hepatitis C infection&#xD;
  &#xD;
            4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not&#xD;
               exclusionary.&#xD;
  &#xD;
            5. Previous related CAR-T cell therapy&#xD;
  &#xD;
            6. Any uncontrolled active medical disorder that would preclude participation&#xD;
  &#xD;
            7. 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_contact>
      <last_name>Lung-Ji Chang, PhD</last_name>
      <phone>86-0755-8672 5195</phone>
      <email>c@szgimi.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ying Deng</last_name>
      <phone>86-0755-8672 5195</phone>
      <email>ying.deng@szgimi.org</email>
    </overall_contact_backup>
    <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>86-0755-86725195</phone>
        <email>c@szgimi.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Hainan Medical University</name>
        <address>
          <city>Haikou</city>
          <state>Hainan</state>
          <zip>570100</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Min Dong, PhD MD</last_name>
        <phone>86-189 7608 3736</phone>
        <email>mingdonghn@hainmc.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Universal CART</keyword>
    <keyword>multiple myelomachimeric antigen BCMA CD38 CD56 CD138 CD19</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>
  
  
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/NCT06006741
  org study id: GIMI-IRB-23003
  nct id: NCT06006741
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T
        cells targeting multiple myeloma. Another goal of the study is to learn more about the
        persistence and function of the universal CAR T cells in the body.
  Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge
        despite advanced therapeutic interventions including novel molecular therapies and stem cell
        transplantation (SCT).
  
        CAR-T therapy has proven to be a revolutionary treatment for hematological malignancies, but
        its manufacture is still limited by the high cost, and a long preparation time that is not
        conducive to timely treatment of patients. In addition, many MM patients suffer from
        long-term bone marrow suppression caused by tumor growth or prolonged and intense
        chemotherapies, resulting in exhaustion, aging and functional defects of autologous T cells,
        which substantially affect the quality of CAR-T cells and the clinical efficacy. The
        universal CAR-T cells could overcome many of the above problems.
  
        By using universal type of CAR-T cells, the product can be supplied off-the-shelf without
        being customized from individual patients. In addition, the immediate availability means that
        patients under severe bone marrow suppression may get a chance to be treated with CAR-T cells
        to achieve disease remission. In addition, those patients who suffer from long-term
        immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have
        the option of treatment with the universal CAR-T cells.
  
        The purpose of this study is to assess the feasibility, safety and efficacy of several 4SCAR
        designs including BCMA, CD138, CD38 and CD19-specific universal CAR-T products targeting MM.
        Another goal is to learn more about the function of these universal CAR T cells and their
        persistency in the patients.
  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: 6 months
  description: percentage of participants with treatment-related adverse events, as assessed by physical examination, vital signs, standard clinical lab tests.
  measure: Anti-tumor activity of the universal 4SCAR-T cells after infusion
  time frame: 3 months
  description: CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
  measure: Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM
  time frame: 1 year
  description: Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
  arm group label: Universal CART cells to treat MM
  arm group type: Experimental
  intervention type: Biological
  intervention name: MM-specific universal CAR T cells
  description: Infusion of MM-specific universal CAR T cells
  arm group label: Universal CART cells to treat MM
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Lung-Ji Chang, PhD
  phone: 86-0755-8672 5195
  email: c@szgimi.org
  last name: Ying Deng
  phone: 86-0755-8672 5195
  email: ying.deng@szgimi.org
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: No