Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.
详细描述
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia and determine the best dosage.
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
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens）
- •To be aged 3 to 75 years
- •Blast in blood ≤ 30%
- •ECOG score ≤2
- •Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
- •Voluntary participation in the clinical trials and sign the informed consent.
排除标准
- •Intracranial hypertension or unconsciousness
- •Respiratory failure
- •CD19 negative
- •Disseminated intravascular coagulation
- •ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x normal value
- •Hematosepsis or Uncontrolled active infection
- •Uncontrolled diabetes
- •Abalienation;
- •WHO Sscore >3
- •Patients in pregnancy or breast-feeding period
- •Previously treatment with any gene therapy products
- •Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
- •Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
研究组 & 干预措施
IM19 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
干预措施: IM19 CAR-T (Biological)
IM19 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
干预措施: fludarabine and cyclophosphamide (Drug)
结局指标
主要结局
Occurrence of study related adverse events
时间窗: 2 years
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
次要结局
- Overall response rate(2 years)