Safety and Efficacy Evaluation of IM19 CAR-T Cells on Refractory or Relapsed B-ALL Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 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 or CD19+ B-all.
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 or CD19+ B-ALL patients and determine the MTD,LTD and 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
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD19+ leukemia, meeting the following criteria
- •At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
- •Less than 1 year between last chemotherapy and progression
- •Not eligible or appropriate for allo-HSCT
- •To be aged 4 to 65 years
- •Estimated survival of ≥ 6 months, but ≤ 2 years
- •ECOG score ≤2
- •Relapse after auto-HSCT
- •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
- •History of epilepsy or other CNS disease
- •Patients have GVHD, which needs treatment with immunosuppressive agents
- •Patients with prolonged QT interval or severe heart disease
- •Patients in pregnancy or breast-feeding period
- •Uncontrolled active infection
- •Active hepatitis B or hepatitis C infection
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
- •Previously treatment with any gene therapy products
- •Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
- •ALT /AST>3 x normal value; Creatinine> 2.5 mg/dl; Bilirubin >2.0 mg/dl
- •Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
- •HIV infection
- •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
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of IM19CART cells administered intravenously.
干预措施: IM19 CAR-T (Biological)
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)