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CAR-T 细胞治疗期间及 ICANS 发生时细胞外囊泡的动态特征

英文原题:Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome

查看英文原题

Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome

ClinicalTrials.gov 2024/11/26(首次登记) IV 期注册临床试验 · 招募中

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

简要介绍

这是一项 IV 期注册临床试验,评估细胞治疗用于多发性骨髓瘤的疗效与安全性。当前状态:招募中。计划入组 60 例。试验地点:欧洲 · 圣艾蒂安(共 1 个中心)。登记号:NCT06706102。

入组条件决定能不能参加

不限性别 · ≥ 18 Years

纳入标准:

• 年龄>18岁。
• 有CAR-T 治疗适应证。
• 参加者加入社会保障体系。
• 同意参加研究。

排除标准:

• 妊娠或哺乳期女性。
• 无法理解知情同意。
• 受法律保护的患者。
核对登记原文(英文)
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnant or breastfeeding woman,
* Patient unable to understand informed consent,
* Patient under legal protection.

以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。

研究终点衡量什么算有效

  • 主要终点内皮细胞来源EV定量(EV/mL)第-7、0、1、2、5、8、15、30和60天
  • 主要终点内皮细胞来源EV表征(免疫表型)第-7、0、1、2、5、8、15、30和60天
  • 次要终点其他亚型EV定量(EV亚型/mL)
  • 次要终点其他亚型EV表征(免疫表型)
  • 次要终点按是否发生ICANS比较EV定量(EV/mL)
  • 次要终点按是否发生ICANS比较EV表征(免疫表型)
  • 次要终点按细胞因子水平评估EV定量(EV/mL)
  • 次要终点按细胞因子水平评估EV表征
  • 次要终点脑脊液中EV定量(EV/mL)
  • 次要终点脑脊液中EV表征
核对登记原文(英文)

主要终点:Endothelial EVs quantification (EVs/mL) · 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. · Days -7, 0, 1, 2, 5, 8, 15, 30 and 60;Endothelial EVs characterization (immunophenotyping) · 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. · Days -7, 0, 1, 2, 5, 8, 15, 30 and 60
次要终点:Other EV subtypes quantification (EV subtype/mL);Other EV subtypes characterization (immunophenotyping);EVS quantification according to the presence of an ICANS versus no ICANS (EV/mL);EVs characterization according to the presence of an ICANS versus no ICANS (immunophenotyping);EVs quantification according to levels of cytokines (EVs/mL);EVs characterization according to levels of cytokines;EVs quantification in cerebrospinal fluid (EVs/mL);EVs characterization in cerebrosinalfluid.

研究设计怎么做的

研究类型
干预性研究
入组人数
60 人(预计)
分组方式
不适用(单臂)
  • CAR-T 细胞治疗试验组

    有CAR-T 治疗适应证的成年患者。

核对分组登记原文(英文)
  • CAR T cell treatment · EXPERIMENTAL · Major patients for whom CAR-T treatment is indicated.

关键日期

开始日期
2025-07-02
主要完成日期
2027-09
全部完成日期
2027-11
登记状态核实于
2026-09

联系与责任方公示信息

申办方
Centre Hospitalier Universitaire de Saint Etienne
联系电话
(0)4 77 82 28 14

以上邮箱 / 电话是登记库里的申办方联系方式(中国内地座机),通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。

登记简述

免疫效应细胞相关神经毒性综合征(ICANS)是CAR-T 细胞治疗常见且严重的神经系统并发症。其机制尚未充分了解,但研究提示,治疗期间的炎症会增加脑组织与血管之间屏障的通透性,并促使细胞外囊泡(EV)释放;EV是参与细胞间通讯并调节多种生理过程的生物颗粒。VESICANS研究将通过流式细胞术、电子显微镜、纳米颗粒跟踪分析,并结合评估血脑屏障的MRI,分析CAR-T 治疗前、治疗期间及ICANS发生时释放的EV。研究最终有望促进这种影响患者预后的毒性的预防和治疗。

核对登记原文(英文)

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.

登记原文与核验信息

试验登记号
NCT06706102
试验期别
IV 期
试验状态
招募中
试验中心(1 个)
法国 1
适应症(原文)
Immune Effector Cell Associated Neurotoxicity Syndrome
干预方式(原文)
Biological tests; MRI; Neuropsychological tests