2024-515328-35-00招募中4 期
Temporal characterization of Extracellular Vesicles during cellular therapy using CAR-T cells and during the occurrence of Immune effector Cell-Associated Neurotoxicity Syndrome : the VESICANS study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quantification and characterization endothelial EVs.
研究概览
简要总结
Describe the characteristics of endothelial EVs and their temporal evolution before and after treatment with CAR-T cells according to ICANS grade.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Patients for whom CAR-T treatment of their disease is indicated
- •Patient affiliated to or entitled under a social security scheme
- •Patient has received informed consent to participate in the study and has co-signed a consent form with the investigator.
排除标准
- •Pregnant or breast-feeding woman
- •Patient unable to understand informed consent
- •Patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).
- •Contraindication to MRI
- •Contraindication to contrast product
结局指标
主要结局
Quantification and characterization endothelial EVs.
Quantification and characterization endothelial EVs.
次要结局
- Quantification and characterization of other EVs subtypes as a function of time before and after treatment with CAR-T cells according to ICANS grade.
- Quantification and characterization of EVs according to the presence of an ICANS versus no ICANS.
- Quantification and characterization of EVs according to levels of cytokines.
- Quantification and structural and molecular characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.
- Characterization of the association of subpopulations of EVs according to clinical neurological impairment and the presence or absence of a sleep apnea syndrome.
- Characterization of the association of EVS subpopulations according to cognitive assessment and MRI before lymphodepleting chemotherapy and at the time of ICANS.
- Description of involvement on MRI before lymphodepleting chemotherapy and at the time of ICANS.
研究者
Project manager
Scientific
Centre Hospitalier Universitaire De Saint Etienne
研究点 (1)
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