Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.
详细描述
CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
- •Refractory or relapsed B cell-acute lymphoblastic leukemia
- •No available curative treatment options (such as hematopoietic stem cell transplantation)
- •Stage III-IV disease
- •Creatinine < 2.5 mg/dl
- •Aspartate transaminase-alanine transaminase ratio < 3x normal
- •Bilirubin < 2.0 mg/dl
- •Karnofsky performance status >= 60
- •Expected survival time > 3 months
- •Adequate venous access for apheresis
- •Ability to understand and provide informed consent
排除标准
- •Pregnant or lactating women
- •Patients requiring T cell immunosuppressive therapy
- •Active central nervous system leukemia
- •Any concurrent active malignancies
- •Patients with a history of a seizure disorder or cardiac disorder
- •Patients with human immunodeficiency virus, hepatitis B or C infection
- •Uncontrolled active infection
结局指标
主要结局
Number of Adverse Events
时间窗: 8 weeks
To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia
次要结局
- Clinical responses to third generation CAR-T cells(2 years)