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
- 试验地点
- 1
- 主要终点
- The effectiveness of CAR-T cell immunotherapy
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 safety 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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The primary GD2 positive patients, the best are glioma patients.
- •The recurrent GD2 positive patients, the best are glioma patients.
- •Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
- •Absolute neutrophil count greater than 1500/mm
- •Platelet count greater than 100,000/mm
- •Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
- •Total bilirubin < 1.5 times upper limits of normal.
- •Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
- •Seronegative for HIV antibody.
- •Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
- •Patients must be willing to practice birth control during and for four months following treatment.
- •NOTE: women of child-bearing age must have evidence of negative pregnancy test.
- •Patients must be willing to sign an informed consent.
排除标准
- •The patients with multiple kinds of cancers are excluded.
- •Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- •Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- •Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- •Pregnant and/or lactating women will be excluded.
- •Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
- •Patients with any type of primary immunodeficiencies will be excluded from the study.
- •Patients requiring corticosteroids (other than inhaled) will be excluded.
- •Patients with history of T cell tumors will be excluded.
- •Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
结局指标
主要结局
The effectiveness of CAR-T cell immunotherapy
时间窗: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
次要结局
- Progress free survival（PFS）(1 year)