Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
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
- Endothelial EVs quantification (EVs/mL)
研究概览
简要总结
Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) is a common and serious neurological complication associated with the use of CAR-T cells. The mechanisms involved are still poorly understood but studies suggest that inflammation during treatment leads to an increase in the permeability of the barrier between the brain and the blood vessels and the emission of extracellular vesicles (EVs) circulating between the brain and the blood vessels. EVs are biological particles that play an important role in cellular communication and the modulation of several physiological processes. The VESICANS study aims to characterize the EVs released before and during CAR-T cells treatment and upon the occurrence of ICANS, using flow cytometry, electron microscopy, Nanoparticle Tracking Analysis associated with MRI assessment of the barrier between the brain and blood. This study will ultimately contribute to facilitating the prevention and treatment of this toxicity which affects the prognosis of patients.
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
- •Patient aged over 18,
- •Patient for whom CAR-T treatment is indicated,
- •Patient affiliated to a social security system
- •Patient who give his consent to participate in the study.
排除标准
- •Pregnant or breastfeeding woman,
- •Patient unable to understand informed consent,
- •Patient under legal protection.
研究组 & 干预措施
CAR T cell treatment
Major patients for whom CAR-T treatment is indicated.
干预措施: Biological tests (Biological)
CAR T cell treatment
Major patients for whom CAR-T treatment is indicated.
干预措施: MRI (Diagnostic Test)
CAR T cell treatment
Major patients for whom CAR-T treatment is indicated.
干预措施: Neuropsychological tests (Diagnostic Test)
结局指标
主要结局
Endothelial EVs quantification (EVs/mL)
时间窗: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Quantification by Nano Tracking Analysis of endothelial EVs as a function of time before and after treatment with CAR-T cells according to ICANS grade.
Endothelial EVs characterization (immunophenotyping)
时间窗: Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
Characterization by Nano Tracking Analysis (immunophenotyping by size) of endothelial EVs as a function of time before and after treatment with CAR-T cells according to ICANS grade.
次要结局
- Other EV subtypes quantification (EV subtype/mL)(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- Other EV subtypes characterization (immunophenotyping)(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- EVS quantification according to the presence of an ICANS versus no ICANS (EV/mL)(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- EVs characterization according to the presence of an ICANS versus no ICANS (immunophenotyping)(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- EVs quantification according to levels of cytokines (EVs/mL)(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- EVs characterization according to levels of cytokines(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- EVs quantification in cerebrospinal fluid (EVs/mL)(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- EVs characterization in cerebrosinalfluid.(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- Association of EVs subpopulations in clinical neurological damage and sleep apnea syndrome.(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- Association of EVs subpopulations in neuropsychological test and RMI.(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)
- Cerabral involvement on RMI(Days -7, 0, 1, 2, 5, 8, 15, 30 and 60)