NCT05809284招募中不适用
Determining the Mechanisms of Loss of CAR T Cell Persistence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Time to circulating CAR-T cell loss
研究概览
简要总结
A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and young adults (age 25 years or younger) with relapsed/refractory ALL who are planned to receive licensed CD19-targeted CAR-T cell treatment (Tisagenlecleucel)
- •Written informed consent
排除标准
- •Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
- •Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol
结局指标
主要结局
Time to circulating CAR-T cell loss
时间窗: Through study completion, until the last patient reaches 1 year post-infusion
CAR-T persistence will be measured in the central lab from blood samples.
次要结局
未报告次要终点
研究者
研究点 (3)
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