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化学抗原受体T细胞疗法诱导的神经系统毒性:基于FDA不良事件报告系统数据库的现实研究

Xiayang Ren¹, Guanmin Zhang², Guohui Li³

¹Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17, Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China.

|January 3, 2024

概括

神经系统毒性 (NST) 是与仿真抗原受体T细胞 (CAR-T) 疗法,特别是抗CD19CAR-Ts.的显著风险. 这种现实世界的分析强调了由于严重的不良事件和延迟发病,需要更多地关注与CAR-T相关的NST.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
药物监督药物监督药物监督

背景情况:

化学抗原受体T细胞 (CAR-T) 疗法为复发性/耐药性血液恶性瘤提供了有效的治疗方法.
神经系统毒性 (NST) 是与CAR-T疗法相关的频繁且严重的不良事件.
关于CAR-T治疗相关的NST的现实数据对于了解其临床影响至关重要.

研究的目的:

评估与CAR-T疗法相关的神经系统毒性 (NST) 的发生率和特征.
通过使用现实数据,分析不同CAR-T产品的NST信号.
评估与CAR-T治疗相关的NST的发病时间和临床结果.

主要方法:

利用了2017年1月至2023年3月的FDA不良事件报告系统 (FAERS) 的数据.
使用不成比例和贝叶斯分析来识别NST信号.
计算报告几率比率 (ROR) 和评估发病时间和临床结果.

主要成果:

确定了6946例与CAR-T疗法相关的NST.
与抗BCMA CAR-T产品相比,抗CD19 CAR-T产品显示出更高的NST信号.
布雷克苏卡巴基因自细胞和轴卡巴基因基洛基因表现出最高的NST信号;含有CD28的CAR-T与大脑有关.

结论:

NST与抗CD19的CAR-Ts和包含CD28.8的那些具有显著的关联.
含有CD28的CAR-Ts可能会增加严重NST的风险,例如脑.
严重不良事件的高比例和与CAR-T相关的NST的延迟发病需要提高临床警.

关键词:

在CAR-T疗法中,美国食品和药物管理局的不良事件报告系统 (FAERS)神经系统毒性毒性神经系统毒性药物监督药物监督药物监督

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