Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Radiological assessment
研究概览
简要总结
This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.
详细描述
Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously identified as CD19+ ALL.
- •ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
- •Expected survival >12W.
- •Creatinine < 2.5 mg/dl.
- •Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
- •Bilirubin <2.0 mg/dl
- •Voluntary informed consent is given.
排除标准
- •Pregnant or lactating women.
- •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.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •HIV infection.
结局指标
主要结局
Radiological assessment
时间窗: Month1 to Month12
Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
次要结局
- The safety of CART immunotherapy(Day 1 to Week 4)