CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma

Conditions
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Glioma of Brain, CAR-T Cell Immunotherapy

Intervention / Treatment
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* Biological: GD2 CAR-T immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GD2 CAR-T<br>Treated by GD2 CAR-T therapy intravenously | Biological: GD2 CAR-T immunotherapy<br>* Antigen-specific T cell therapy<br>* Other names: CAR-T for glioma;|
| No Intervention: Control<br>With no medical intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of adverse reactions | To observe the common 1-4 levels of side effects | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GD2, CAR-T cell immunotherapy, glioma