Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Classification of adverse reactions
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with cardiac pacemaker
- •Patients with brain metastasis
- •Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
结局指标
主要结局
Classification of adverse reactions
时间窗: 3 months
To observe the common 1-4 levels of side effects
次要结局
- Progression free survival （PFS）of patients(1 year)