Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of adverse events
研究概览
简要总结
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
详细描述
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 1 year;
- •CD19 positive B-cell acute lymphoblastic leukemia;
- •Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
- •Expected to survive for more than 3 months;
- •Informed consent is signed by a subject or his lineal relation.
排除标准
- •Recent or current use of glucocorticoid or other immunosuppressor;
- •Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- •Has a graft-versus-host response and requires the use of immunosuppressants；
- •Drug uncontrollable central nervous system leukemia；
- •Pregnant or lactating female；
- •The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
- •A history of other malignant tumors;
- •The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
研究组 & 干预措施
CD19-CAR-T Cells
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
干预措施: CD19 CAR-T cells (Biological)
结局指标
主要结局
Percentage of adverse events
时间窗: 6 months
Percentage of participants with adverse events
次要结局
- complete remission rate(6 months)
- objective remission rate(6 months)