NCT03327285Unknown不适用
A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- TEAEs
研究概览
简要总结
This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
详细描述
A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10^6CAR+T cells/kg
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15-65 years old, male or female.
- •Volunteered to participate in this study and signed informed consent.
- •Meet the two populations above.
- •Histologically diagnosed as CD19+B-ALL.
- •100% T lymphocytes of donor.
- •Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
- •Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
- •Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
- •Expected survival ≧ 3 months.
- •Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
排除标准
- •History of allergy to cellular products.
- •Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L.
- •The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
- •Severe uncontrolled infection (mycotic, bacterial, virus and so on).
- •Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
- •The subjects were treated CART cells or DLI after HSCT.
- •Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
- •Any genetically modified T cell therapy.
- •History of heavy drinking, drug taking or mental disease.
- •Participated in any other clinical trial within one month prior to enrollment.
- •Women who are pregnant or lactating or have breeding intent in 6 months.
- •The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
结局指标
主要结局
TEAEs
时间窗: 2 months
TEAEs evaluated after C-CAR011 infusion
GVHD
时间窗: 2 months
GVHD evaluated after C-CAR011 infusion
次要结局
- Recurrence rate(6 and 12 months)
- PFS(12 months)
- OS(12 months)
- Remission rate(2 weeks to 3 months)
研究者
Xiaojun Huang,MD
Chair
Peking University People's Hospital
研究点 (1)
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