NCT03614858招募中1 期
Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
详细描述
The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
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
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows:
- •Age 6-65 years.
- •Left ventricular ejection fractions≥ 0.5 by echocardiography.
- •Creatinine < 1.6 mg/dL.
- •Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
- •Bilirubin <2.0 mg/dL.
- •Karnofsky performance status ≥ 60
- •Expected survival time ≥ 3 months (according to investigator's judgement)
排除标准
- •Pregnant or lactating women.
- •Uncontrolled active infection.
- •Active hepatitis B or hepatitis C infection.
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- •HIV infection.
- •Patients with history of seizure
- •Active central nervous system leukemia
结局指标
主要结局
Number of Adverse Events
时间窗: 12 months
Adverse events are evaluated with CTCAE V4.03
次要结局
未报告次要终点
研究者
研究点 (1)
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