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CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

Primary Purpose

Glioma of Brain, CAR-T Cell Immunotherapy

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
GD2 CAR-T immunotherapy
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma of Brain focused on measuring CAR-T cell immunotherapy, GD2, glioma

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  • Body tumor 1-6, the maximum tumor length < 2 cm
  • KPS ≥ 70, lifespan > 6 months
  • Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    GD2 CAR-T

    Control

    Arm Description

    Treated by GD2 CAR-T therapy intravenously

    With no medical intervention

    Outcomes

    Primary Outcome Measures

    Classification of adverse reactions
    To observe the common 1-4 levels of side effects

    Secondary Outcome Measures

    Progression free survival （PFS）of patients
    PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.

    Full Information

    First Posted
    September 10, 2019
    Last Updated
    July 14, 2020
    Sponsor
    Fuda Cancer Hospital, Guangzhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04406610
    Brief Title
    CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients
    Official Title
    Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Project terminated due to revision of local regulations
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    August 15, 2016 (Actual)
    Study Completion Date
    October 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fuda Cancer Hospital, Guangzhou

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioma of Brain, CAR-T Cell Immunotherapy
    Keywords
    CAR-T cell immunotherapy, GD2, glioma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GD2 CAR-T
    Arm Type
    Experimental
    Arm Description
    Treated by GD2 CAR-T therapy intravenously
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    With no medical intervention
    Intervention Type
    Biological
    Intervention Name(s)
    GD2 CAR-T immunotherapy
    Other Intervention Name(s)
    CAR-T for glioma
    Intervention Description
    Antigen-specific T cell therapy
    Primary Outcome Measure Information:
    Title
    Classification of adverse reactions
    Description
    To observe the common 1-4 levels of side effects
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Progression free survival （PFS）of patients
    Description
    PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence Body tumor 1-6, the maximum tumor length < 2 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

    12. IPD Sharing Statement

    Learn more about this trial

    CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

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