<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/NCT04406610</url>
  </required_header>
  <id_info>
    <org_study_id>CAR-T</org_study_id>
    <nct_id>NCT04406610</nct_id>
  </id_info>
  <brief_title>CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients</brief_title>
  <official_title>Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuda Cancer Hospital, Guangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fuda Cancer Hospital, Guangzhou</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell&#xD;
      immunotherapy in treating with GD2 positive glioma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T&#xD;
      cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages&#xD;
      compared with conventional immunotherapy, especially in dealing with patients of hematologic&#xD;
      malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen&#xD;
      receptor aiming at GD2 antigen.After CAR-T cell infusion,At periodic intervals, the&#xD;
      investigators will evaluate clinical symptoms Improved conditions of this disease.Through&#xD;
      this study,the investigators will evaluate the safty and effectiveness of CAR-T cell&#xD;
      immunotherapy in treating with GD2 positive glioma patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Project terminated due to revision of local regulations&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">October 15, 2016</completion_date>
  <primary_completion_date type="Actual">August 15, 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Classification of adverse reactions</measure>
    <time_frame>3 months</time_frame>
    <description>To observe the common 1-4 levels of side effects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival （PFS）of patients</measure>
    <time_frame>1 year</time_frame>
    <description>PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Glioma of Brain</condition>
  <condition>CAR-T Cell Immunotherapy</condition>
  <arm_group>
    <arm_group_label>GD2 CAR-T</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treated by GD2 CAR-T therapy intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>With no medical intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GD2 CAR-T immunotherapy</intervention_name>
    <description>Antigen-specific T cell therapy</description>
    <arm_group_label>GD2 CAR-T</arm_group_label>
    <other_name>CAR-T for glioma</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All standard therapies have failed according to NCCN guidelines or the patient refuses&#xD;
             standard therapies after cancer recurrence&#xD;
&#xD;
          -  Body tumor 1-6, the maximum tumor length &lt; 2 cm&#xD;
&#xD;
          -  KPS ≥ 70, lifespan &gt; 6 months&#xD;
&#xD;
          -  Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥&#xD;
             2×109/L, hemoglobin ≥ 80 g/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiac pacemaker&#xD;
&#xD;
          -  Patients with brain metastasis&#xD;
&#xD;
          -  Patients with grade 3 hypertension or diabetic complication, severe cardiac and&#xD;
             pulmonary dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 10, 2019</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAR-T cell immunotherapy</keyword>
  <keyword>GD2</keyword>
  <keyword>glioma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04406610
org study id: CAR-T
nct id: NCT04406610
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell
      immunotherapy in treating with GD2 positive glioma patients.
Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T
      cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages
      compared with conventional immunotherapy, especially in dealing with patients of hematologic
      malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen
      receptor aiming at GD2 antigen.After CAR-T cell infusion,At periodic intervals, the
      investigators will evaluate clinical symptoms Improved conditions of this disease.Through
      this study,the investigators will evaluate the safty and effectiveness of CAR-T cell
      immunotherapy in treating with GD2 positive glioma patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Classification of adverse reactions
time frame: 3 months
description: To observe the common 1-4 levels of side effects
measure: Progression free survival （PFS）of patients
time frame: 1 year
description: PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.
arm group label: GD2 CAR-T
arm group type: Experimental
description: Treated by GD2 CAR-T therapy intravenously
arm group label: Control
arm group type: No Intervention
description: With no medical intervention
intervention type: Biological
intervention name: GD2 CAR-T immunotherapy
description: Antigen-specific T cell therapy
arm group label: GD2 CAR-T
other name: CAR-T for glioma
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Glioma
mesh term: Immunomodulating Agents