NCT05054231尚未招募不适用
Immunological Profile for Patients Treated With CAR-T Cells
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年10月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion
研究概览
简要总结
In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.
A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Planned injection of CAR-T cells within the scope of marketing authorization
- •Signed informed consent
- •French social security affiliation
排除标准
- •Pregnant women, or women of childbearing potential (without medically acceptable contraception) or breastfeeding women.
- •Patient in emergency situation, adult under legal protection (patient placed under tutorship, curatorship, or judicial protection) or unable to give his consent
- •Impossibility to comply with trial medical follow-up for geographic, social or psychological reasons
结局指标
主要结局
Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion
时间窗: 1 year after T cells infusion
Serum concentration of cytokines in relation to adverse events
次要结局
- Number of participants with a cytokine release syndrome(From CAR-T cells infusion to one year)
- CAR-T cells rate from infusion to one year after CAR-T cells infusion(From CAR-T cells infusion to one year)
- Number of participants with a relapse(From CAR-T cells infusion to one year)
研究者
研究点 (2)
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