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/NCT05995015</url>
    </required_header>
    <id_info>
      <org_study_id>GIMI-IRB-23001</org_study_id>
      <nct_id>NCT05995015</nct_id>
    </id_info>
    <brief_title>4SCAR19U T Cells Targeting B Cell Malignancies</brief_title>
    <official_title>Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies</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>
      <collaborator>
        <agency>Beijing Jingdu Children's Hospital</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 purpose of this study is to assess the feasibility, safety and efficacy of universal CAR&#xD;
        T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific&#xD;
        CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of&#xD;
        the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling&#xD;
        patients from multiple clinical centers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell&#xD;
        malignancies. However, the application itself is still limited by the high cost and long&#xD;
        preparation time which often do not meet the urgent need of patients. In addition, some&#xD;
        patients may suffer from long-term immunosuppression caused by tumor microenvironment or&#xD;
        after radiotherapy and chemotherapy, resulting in exhaustion, aging and functional defects of&#xD;
        the autologous T cells, which will eventually affect the quality of the CAR-T cells and&#xD;
        affect the clinical efficacy.&#xD;
  &#xD;
        The 4SCAR19U T cells are genetically engineered and manufactured in bulk amount that can be&#xD;
        supplied off-the-shelf without being custom made from individual patients. The immediate&#xD;
        availability of the CAR-T cells makes clinical treatment convenient and timely for rapid&#xD;
        progressing disease or for the highly immune suppressed patients. This application can be&#xD;
        time- and cost-effective. This novel approach may also overcome problems of functionally&#xD;
        defective autologous T cells. The purpose of this clinical trial is to assess the&#xD;
        feasibility, safety and efficacy of the 4SCAR19U T cell product in hematological&#xD;
        malignancies. Another goal of the study is to learn more about the function of this novel&#xD;
        product and its persistence in the patients&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 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>Safety of 4SCAR19U CAR-T cells infusion</measure>
      <time_frame>24 weeks</time_frame>
      <description>Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anti-tumor activity of 4SCAR19U cells after infusion</measure>
      <time_frame>1 year</time_frame>
      <description>Objective responses (complete response (CR) + partial response (PR)) are 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">30</enrollment>
    <condition>B Cell Malignancies</condition>
    <arm_group>
      <arm_group_label>Universal 4SCAR19U cells to treat CD19-positive hematological malignancies</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Universal CD19-specific CAR gene-engineered T cells</intervention_name>
      <description>Infusion of 4SCAR19U cells</description>
      <arm_group_label>Universal 4SCAR19U cells to treat CD19-positive hematological malignancies</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age older than 6 months.&#xD;
  &#xD;
            2. Primary B cell surface expression of CD19.&#xD;
  &#xD;
            3. The KPS score over 80 points, and survival time is more than 1 month.&#xD;
  &#xD;
            4. Greater than Hgb 80 g/L.&#xD;
  &#xD;
            5. No contraindications to blood cell collection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Accompanied with other active diseases, and difficult to assess response after&#xD;
               treatment.&#xD;
  &#xD;
            2. Bacterial, fungal, or viral infection, unable to control.&#xD;
  &#xD;
            3. Living with HIV.&#xD;
  &#xD;
            4. Active HBV or HCV infection.&#xD;
  &#xD;
            5. Pregnant and nursing mothers.&#xD;
  &#xD;
            6. under systemic steroid treatment within a week of the treatment.&#xD;
  &#xD;
            7. Prior failed CAR-T treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lung-Ji Chang, Ph.D</last_name>
      <phone>+86-0755 8672-5195</phone>
      <email>c@szgimi.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Jingdu Children's Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Juan Xiao, PhD,MD</last_name>
        <phone>86-15801071228</phone>
        <email>15801071228@163.com</email>
      </contact>
    </location>
    <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, Ph.D</last_name>
        <phone>+86-0755 8672-5195</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>86-18976083736</phone>
        <email>mindonghn@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 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Universal CAR-T</keyword>
    <keyword>CD19 B-ALL</keyword>
    <keyword>PMBCL</keyword>
    <keyword>CNS-BCL</keyword>
    <keyword>BCL</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</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/NCT05995015
  org study id: GIMI-IRB-23001
  nct id: NCT05995015
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR
        T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific
        CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of
        the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling
        patients from multiple clinical centers.
  Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell
        malignancies. However, the application itself is still limited by the high cost and long
        preparation time which often do not meet the urgent need of patients. In addition, some
        patients may suffer from long-term immunosuppression caused by tumor microenvironment or
        after radiotherapy and chemotherapy, resulting in exhaustion, aging and functional defects of
        the autologous T cells, which will eventually affect the quality of the CAR-T cells and
        affect the clinical efficacy.
  
        The 4SCAR19U T cells are genetically engineered and manufactured in bulk amount that can be
        supplied off-the-shelf without being custom made from individual patients. The immediate
        availability of the CAR-T cells makes clinical treatment convenient and timely for rapid
        progressing disease or for the highly immune suppressed patients. This application can be
        time- and cost-effective. This novel approach may also overcome problems of functionally
        defective autologous T cells. The purpose of this clinical trial is to assess the
        feasibility, safety and efficacy of the 4SCAR19U T cell product in hematological
        malignancies. Another goal of the study is to learn more about the function of this novel
        product and its persistence in the patients
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety of 4SCAR19U CAR-T cells infusion
  time frame: 24 weeks
  description: Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events
  measure: Anti-tumor activity of 4SCAR19U cells after infusion
  time frame: 1 year
  description: Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
  arm group label: Universal 4SCAR19U cells to treat CD19-positive hematological malignancies
  arm group type: Experimental
  intervention type: Biological
  intervention name: Universal CD19-specific CAR gene-engineered T cells
  description: Infusion of 4SCAR19U cells
  arm group label: Universal 4SCAR19U cells to treat CD19-positive hematological malignancies
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 75 Years
  healthy volunteers: No
  last name: Lung-Ji Chang, Ph.D
  phone: +86-0755 8672-5195
  email: c@szgimi.org
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No