<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/NCT03252171</url>
  </required_header>
  <id_info>
    <org_study_id>CAR-T for GD2 positive glioma</org_study_id>
    <nct_id>NCT03252171</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 safety 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Withdrawn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">October 15, 2015</start_date>
  <completion_date type="Actual">August 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effectiveness of CAR-T cell immunotherapy</measure>
    <time_frame>3 months</time_frame>
    <description>It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress free survival（PFS）</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival（OS）</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>GD2 Positive Glioma</condition>
  <condition>CAR-T Cell Immunotherapy</condition>
  <arm_group>
    <arm_group_label>Experimental: CAR-T cell immunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen by infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CAR-T cell immunotherapy</intervention_name>
    <description>This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.</description>
    <arm_group_label>Experimental: CAR-T cell immunotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The primary GD2 positive patients, the best are glioma patients.&#xD;
&#xD;
          2. The recurrent GD2 positive patients, the best are glioma patients.&#xD;
&#xD;
          3. Patients must have evidence of adequate bone marrow reserve, hepatic and renal&#xD;
             function as evidenced by the following laboratory parameters:&#xD;
&#xD;
               -  Absolute neutrophil count greater than 1500/mm3.&#xD;
&#xD;
               -  Platelet count greater than 100,000/mm3.&#xD;
&#xD;
               -  Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this&#xD;
                  parameter).&#xD;
&#xD;
               -  Total bilirubin &lt; 1.5 times upper limits of normal.&#xD;
&#xD;
               -  Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must&#xD;
                  be greater than 70 ml/min/1.73m(2).&#xD;
&#xD;
               -  Seronegative for HIV antibody.&#xD;
&#xD;
               -  Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.&#xD;
&#xD;
          4. Patients must be willing to practice birth control during and for four months&#xD;
             following treatment.&#xD;
&#xD;
             NOTE: women of child-bearing age must have evidence of negative pregnancy test.&#xD;
&#xD;
          5. Patients must be willing to sign an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients with multiple kinds of cancers are excluded.&#xD;
&#xD;
          2. Patients with uncontrolled hypertension (&gt; 160/95), unstable coronary disease&#xD;
             evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart&#xD;
             failure (&gt; New York Heart Association Class II), or myocardial infarction within 6&#xD;
             months of study will be excluded.&#xD;
&#xD;
          3. Patients with any of the following pulmonary function abnormalities will be excluded:&#xD;
             FEV(forced expiratory volume), &lt; 30% predicted; DLCO (diffusing capacity of lung for&#xD;
             carbon monoxide) &lt; 30% predicted (post-bronchodilator); Oxygen Saturation less than&#xD;
             90% on room air.&#xD;
&#xD;
          4. Patients with severe liver and kidney dysfunction or consciousness disorders will be&#xD;
             excluded.&#xD;
&#xD;
          5. Pregnant and/or lactating women will be excluded.&#xD;
&#xD;
          6. Patients with active infections, including HIV, will be excluded, due to unknown&#xD;
             effects of the vaccine on lymphoid precursors.&#xD;
&#xD;
          7. Patients with any type of primary immunodeficiencies will be excluded from the study.&#xD;
&#xD;
          8. Patients requiring corticosteroids (other than inhaled) will be excluded.&#xD;
&#xD;
          9. Patients with history of T cell tumors will be excluded.&#xD;
&#xD;
         10. Patients who are participating or participated any other clinical trials in latest 30&#xD;
             days will be excluded.&#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>Lizhi Niu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Fuda Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central laboratory in Fuda cancer hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 18, 2015</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</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/NCT03252171
org study id: CAR-T for GD2 positive glioma
nct id: NCT03252171
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 safety and effectiveness of CAR-T cell
      immunotherapy in treating with GD2 positive glioma patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The effectiveness of CAR-T cell immunotherapy
time frame: 3 months
description: It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
measure: Progress free survival（PFS）
time frame: 1 year
measure: Overall survival（OS）
time frame: 3 years
arm group label: Experimental: CAR-T cell immunotherapy
arm group type: Experimental
description: Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen by infusion.
arm group label: No Intervention
arm group type: No Intervention
intervention type: Biological
intervention name: CAR-T cell immunotherapy
description: This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.
arm group label: Experimental: CAR-T cell immunotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lizhi Niu, PhD
role: Study Chair
affiliation: Fuda Cancer Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Glioma
mesh term: Immunomodulating Agents