A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.
详细描述
This study is being conducted to evaluate the safety and efficacy of Chimeric antigen receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In the research, the investigators design a novel CAR consists of a EpCAM targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. The infusion dose is (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation. The way of infusion is vascular interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to 30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory EpCAM positive cancer.
- •Life expectancy>3 months.
- •Gender unlimited, age from 18 years to 80 years.
- •Assessable lesions with a minimum size of 10mm by CT scan or MRI.
- •Acceptable organ function Hematology:
- •Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.
- •White blood cell (WBC) (> 2000/mm^3).
- •Platelet count greater than 50,000/mm^
- •Hemoglobin greater than 9.0 g/dl.
- •No other serious diseases(autoimmune disease, immunodeficiency etc.).
- •Adequate cardiac function (LVEF ≥ 40%).
- •No other tumors.
- •Patients volunteer to participate in the research.
排除标准
- •Allergic to cytokines.
- •Uncontrolled active infection.
- •Acute or chronic GVHD.
- •Treated with T cell inhibitor.
- •HIV affected.
结局指标
主要结局
Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
时间窗: up to 24 months
Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
次要结局
- Survival time of anti-EpCAM CAR T cells in vivo(up to 24 months)
- Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1(up to 24 months)