An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Safety and Efficacy of Intratumoral Delivery Mediated MG7-targeted Chimeric Antigen Receptor T Cells in Advanced MG7 Positive Liver Metastases
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients with adverse event
研究概览
简要总结
The purpose of this study is to collect the data on the safety and potential effectiveness of intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver metastases expressing MG7 positively.
详细描述
Designer T cells are prepared by PBMC which from patients by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs) specific for MG7, which is a glycosylated protein of CEA. Cells are expanded in culture and returned to the participant by intra-tumor injection at the dose of (1-6)×108 CAR positive T cells. The cells perfusion process would last for 1min to 2min. The dose of 1.5 grams/m2 of cyclophosphamide will be given two days before CART cell infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MG7 expression positive by histologically confirmed;
- •Aged between 18 and 69;
- •Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients;
- •Tumor is too big to surgical resection;
- •Life expectancy greater than 4 months;
- •Satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) cardiac ejection fraction of >55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit;
- •Without bleeding disorder or coagulation disorders;
- •Dont allergy to Radiocontrast agent;
- •Birth control;
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis;
- •Voluntary informed consent is given.
排除标准
- •Pregnant or lactating women;
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
- •Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before;
- •Four weeks before recruit accepted radiation therapy;
- •Previously treatment with any gene therapy products;
- •Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation;
- •Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases);
- •Patient with severe acute hypersensitive reaction;
- •Taking part in other clinical trials;
- •Study leader considers not suitable for this tiral.
结局指标
主要结局
Number of patients with adverse event
时间窗: 6 weeks
adverse event is evaluated with CTCAE, version 4.0
次要结局
- Number of patients with tumor response(8 weeks)
- Detection of transferred T cells in the circulation using quantitative -PCR(8 weeks)