CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
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
Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
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。
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。
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。
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。
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.
有CAR-T 治疗适应证的成年患者。
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。
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。
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.
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