<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/NCT03232619</url>
  </required_header>
  <id_info>
    <org_study_id>SHBYCL001</org_study_id>
    <nct_id>NCT03232619</nct_id>
  </id_info>
  <brief_title>CD19-CART Treatment for ALL</brief_title>
  <official_title>Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioray Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bioray Laboratories</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of&#xD;
      refractory or recurrent ALL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring&#xD;
      an artificial antigen binding receptor and also intercellular co-stimulating molecules into T&#xD;
      cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor&#xD;
      cells and initiate the killing process in a HLA-independent way. CD19 is the specific&#xD;
      cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in&#xD;
      treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is&#xD;
      equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a&#xD;
      humanized scFv. This study aims to evaluate the safety and efficacy of both murine and&#xD;
      humanized CD19-CART in treating refractory or recurrent ALL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 6, 2020</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Enrolled patients will receive CD19-CART cell immunotherapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological assessment</measure>
    <time_frame>Month1 to Month12</time_frame>
    <description>Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The safety of CART immunotherapy</measure>
    <time_frame>Day 1 to Week 4</time_frame>
    <description>After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Acute Leukemia</condition>
  <arm_group>
    <arm_group_label>CD19-CART with a murine scFv</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled patients in this arm will receive CD19-CART with a murine scFv.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>humanized CD19-CART</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled patients in this arm will receive humanized CD19-CART.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CD19 CART</intervention_name>
    <description>Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.</description>
    <arm_group_label>CD19-CART with a murine scFv</arm_group_label>
    <arm_group_label>humanized CD19-CART</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. previously identified as CD19+ ALL.&#xD;
&#xD;
          2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.&#xD;
&#xD;
          3. Expected survival &gt;12W.&#xD;
&#xD;
          4. Creatinine &lt; 2.5 mg/dl.&#xD;
&#xD;
          5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) &lt; 3x normal&#xD;
&#xD;
          6. Bilirubin &lt;2.0 mg/dl&#xD;
&#xD;
          7. Voluntary informed consent is given.&#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. Previously treatment with any gene therapy products.&#xD;
&#xD;
          6. Any uncontrolled active medical disorder that would preclude participation as&#xD;
             outlined.&#xD;
&#xD;
          7. HIV infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunxiao Xu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Bioray Inc.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200240</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>September 20, 2020</last_update_submitted>
  <last_update_submitted_qc>September 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03232619
org study id: SHBYCL001
nct id: NCT03232619
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of
      refractory or recurrent ALL.
Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring
      an artificial antigen binding receptor and also intercellular co-stimulating molecules into T
      cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor
      cells and initiate the killing process in a HLA-independent way. CD19 is the specific
      cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in
      treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is
      equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a
      humanized scFv. This study aims to evaluate the safety and efficacy of both murine and
      humanized CD19-CART in treating refractory or recurrent ALL.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Enrolled patients will receive CD19-CART cell immunotherapy.
primary purpose: Treatment
masking: None (Open Label)
measure: Radiological assessment
time frame: Month1 to Month12
description: Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
measure: The safety of CART immunotherapy
time frame: Day 1 to Week 4
description: After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity
arm group label: CD19-CART with a murine scFv
arm group type: Experimental
description: All enrolled patients in this arm will receive CD19-CART with a murine scFv.
arm group label: humanized CD19-CART
arm group type: Experimental
description: All enrolled patients in this arm will receive humanized CD19-CART.
intervention type: Biological
intervention name: CD19 CART
description: Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.
arm group label: CD19-CART with a murine scFv
arm group label: humanized CD19-CART
criteria: 
gender: All
minimum age: 6 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yunxiao Xu, MD
role: Principal Investigator
affiliation: Second Xiangya Hospital of Central South University
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No