Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
详细描述
Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.
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
- 1 Year 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
- •Karnofsky or Lansky performance scale greater or equal to 70;
- •T-cells count in peripheral blood >150 cells/µL;
- •Written informed consent.
排除标准
- •primary immunodeficiencies or genetic syndromes;
- •neurologic diseases;
- •autoimmune diseases or polyallergie;
- •transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
- •GvHD grade 2-4;
- •uncontrolled systemic infection;
- •hypoxia (Sp02<90%)
- •severe hepatic dysfunction: ALT or AST >=3x upper limit of normal for age;
- •renal dysfunction: serum creatinine level >=3x upper limit of normal for age;
- •positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
- •pregnancy.
研究组 & 干预措施
CD19 CAR-T cells immunotherapy
After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
干预措施: CD19 CAR-T-cells (Biological)
CD19 CAR-T cells immunotherapy
After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 1 month
Adverse events will be graded according to the CTCAE v5.0
次要结局
- Objective Response Rate (ORR) (CR+CRi+CRm)(28 days after CAR-T cells infusion)
- Leukemia free survival (LFS)(1 year)
- Overall survival (OS)(1 year)
- Events free survival (EFS)(1 year)