Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of adverse events after anti-CD5 CAR T cells cell infusion
研究概览
简要总结
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.
详细描述
Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent; Patients volunteer to participate in the research
- •Diagnosis is mainly based on the World Health Organization (WHO) 2008
- •Patients have exhausted standard therapeutic options
- •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
- •Female must be not pregnant during the study
排除标准
- •Patients declining to consent for treatment
- •Prior solid organ transplantation
- •Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- •Any drug used for GVHD must be stopped >1 week
研究组 & 干预措施
anti-CD5 CAR T cells
Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg
干预措施: anti-CD5 CAR T cells (Drug)
结局指标
主要结局
Number of adverse events after anti-CD5 CAR T cells cell infusion
时间窗: 2 years particularly the first 28 days after infusion
Determine the toxicity profile of anti-CD5 CAR T cell therapy
次要结局
- Disease Free Survival (DFS)(up to 2 years)
- Incidence of treatment-emergent adverse events(up to 6 months)
- Progression-Free Survival (PFS)(up to 2 years)
- Overall Survival (OS)(up to 2 years)