Phase I/II Study of EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
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
- Safety: Occurrence of study related adverse events
研究概览
简要总结
This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients with colorectal cancer.
详细描述
This is a study for the patients with colorectal cancer. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that EGFR:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. Fourth generation CART, also known as TRUCKs (T cells redirected for universal cytokine before), mainly in order to improve the effect of solid tumor treatment and design, through NFAT transcription factors inducing expression of IL - 12, overcome the solid tumor within the tumor microenvironment of CART limit the function of cellsThe purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with metastatic colorectal cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years to 70 years;
- •Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
- •Patients must have a KPS of >80, expected survival > 3 months;
- •Patients must have at least one measurable lesions;
- •Recently did not use glucocorticoid;
- •Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L）; AST ≤2.5ULN，ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN，
- •Patients must have a good heart function (LVEF>50%) ;
- •Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment；
- •Patients must be willing to sign an informed consent.
排除标准
- •Patients with other cancer history;
- •Patients allergic to cetuximab;
- •Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
- •Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
- •Patients with acute and chronic GVHD (graft versus host disease)
- •Patients with severe autoimmune diseases;
- •Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
- •Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
- •Patients who are participating or participated any other clinical research in the past 1 months;
- •Pregnant and/or lactating women will be excluded; -
研究组 & 干预措施
3
anti-tumor response of EGFR IL12 CART
干预措施: EGFR IL12 CART (Biological)
结局指标
主要结局
Safety: Occurrence of study related adverse events
时间窗: 24 weeks
Occurrence of study related adverse events as assessed by CTCAE v4.0
次要结局
- Effectiveness: duration of in vivo survival of EGFR CART(1 year)
- Effectiveness: Changes of tumor markers(24 weeks)
研究者
tiangeng
Chief physician
Shenzhen Second People's Hospital