CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

Fuda Cancer Hospital, Guangzhou

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Glioma of Brain CAR-T Cell Immunotherapy

Interventions

GD2 CAR-T immunotherapyBIOLOGICAL

Antigen-specific T cell therapy

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Classification of adverse reactions

To observe the common 1-4 levels of side effects

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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