Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 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-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML
详细描述
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML 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 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD123+ Refractory or Relapsed AML
- •To be aged 3 to 80 years
- •Expression of CD123 in Blast ≥90%
- •ECOG score ≤2
- •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;
- •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
研究组 & 干预措施
IM23 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD123 CAR will be infused 24-96 hours later.
干预措施: IM23 (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
未报告次要终点