Phase I Clinical Trial Evaluating the Safety and Efficacy of Point-of-care CAR-T-cell Therapy in the Treatment of Relapsed/Refractory CD19+ Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy
研究概览
简要总结
- Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR).
- Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
- Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
- Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
详细描述
Objectives:
-
Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy.
-
Evaluate the response rate after CD19 CAR T-cell infusion according to the following criteria:
-
Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion
-
Progression-free survival (PFS) after infusion of CD19 CAR T-cells
-
Event-free survival (EFS) after infusion of CD19 CAR T-cells
-
Overall survival (OS) after infusion of CD19 CAR T-cells
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment Regimen
- Experimental: Treatment Regimen.
- Leukapheresis to collect white blood cells using Spectra Optia Apheresis system.
- T cells selection, transduction, and CAR T-cell manufacturing using CliniMACS Prodigy. During this process, T cells will be genetically modified to express CD19 CAR.
- Lymphodepleting chemotherapy conditioning regimen for 3 days.
- CAR T-cells targeting CD19 will be infused intravenously at a dose between 1 and 2x10e6 cells/kg for 15-30 minutes.
- Following the T-cell infusion, patients will stay in the clinic for approximately 21-28 days to monitor toxicity.
- Outpatient follow-up will take place after 1 month, 3 months, and 6 months after infusion.
干预措施: anti-CD19 CAR T-cells (Biological)
结局指标
主要结局
Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy
时间窗: 6 months
The incidence of adverse events (AEs) and serious adverse events (SAEs) will be recorded and classified according to CTCAE v5 (grade 1-5). CRS and ICANs will be classified using the ASTCT criteria (grade 1-5). These parameters will be used to assess the safety of the therapy.
次要结局
- Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion (%)(Day 30 and day 90 after CAR-T infusion for B-ALL; day 90 after CAR-T infusion for NHL)
- Progression-free survival (PFS) (months)(6 months)
- Event-free survival (EFS) (months)(6 months)
- Overall survival (OS) (months)(6 months)