Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
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
- Progression-Free Survival
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 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma.
详细描述
This is a study for the patients with B cell lymphoma. 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 CD19:4-1BB: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. The purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with relapsed and refractory CD19+ B cell lymphoma.
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
- •18 years to 70 years, expected survival > 3 months;
- •CD19 positive B-cell lymphoma;
- •Having at least one measurable lesions;
- •Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;
- •No serious allergic constitution;
- •No other serous diseases that conflicts with the clinical program;
- •No other cancer history;
- •No serious mental disorder;
- •Informed consent is signed by a subject or his lineal relation.
排除标准
- •Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- •Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- •Active hepatitis B or hepatitis C infection;
- •Recent or current use of glucocorticoid or other immunosuppressor;
- •With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- •Transaminase >2.5ULN, Bilirubin >3ULN，Creatinine>1.25ULN
- •Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
- •Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;
研究组 & 干预措施
CD19 CART
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2.
干预措施: Fludarabine (Drug)
CD19 CART
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2.
干预措施: Cyclophosphamide (Drug)
CD19 CART
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2.
干预措施: CD19 CART (Biological)
结局指标
主要结局
Progression-Free Survival
时间窗: 2 years
observe the maximum tolerated dose (MTD)
时间窗: 2 months
objective response rate
时间窗: 2 years
CR+PR
disease control rate
时间窗: 2 years
CR+PR+SD
overall survival
时间窗: 2 years
OS
safety as assessed by the occurence of study related adverse events
时间窗: 6 months
monitor the occurence of study related adverse events
次要结局
- Peripheral blood cytokines(2 months)
- subgroup of T cell(2 years)
- Determine duration of in vivo survival of CD19 CART cells(2 years)