The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- safety as assessed by the occurrence of study related adverse events.
研究概览
简要总结
This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.
详细描述
Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.
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
- 4 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 years to 70 years, expected survival > 3 months
- •CD19 positive B-cell acute lymphoblastic leukemia
- •Karnofsky Performance Status (KPS) >70
- •Relapsed after allogeneic or autologous stem cell transplantation (SCT);
- •Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (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 >2.5 ULN, Bilirubin >3 ULN，Creatinine>1.25 ULN
- •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
CART-19
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
干预措施: Cyclophosphamide (Drug)
CART-19
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
干预措施: Fludarabine (Drug)
CART-19
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
干预措施: CART-19 cells (Biological)
结局指标
主要结局
safety as assessed by the occurrence of study related adverse events.
时间窗: 6 months
monitor the occurrence of study related adverse events.
次要结局
- duration of CART-19(2 years)
- efficacy(2 years)
研究者
Yongping Song
director
Henan Cancer Hospital