CD19 CAR T细胞治疗和预防性阿纳金拉在复发性或耐药性淋巴瘤:第二阶段试验临时结果
Jae H Park1,2,3, Karthik Nath4, Sean M Devlin5
1Cellular Therapy Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City, NY, USA. parkj6@mskcc.org.
Nature medicine
|July 3, 2023
概括
作为IL-1受体对抗剂的Anakinra在接受CAR T细胞治疗的淋巴瘤患者中显著降低了严重的神经毒性 (ICANS). 这种治疗保持了抗癌疗效,这表明anakinra.
科学领域:
- 血液学 血液学 血液学
- 免疫学 免疫学 免疫学
- 在瘤学瘤学.
背景情况:
- 化学抗原受体 (CAR) T细胞疗法为复发性/耐药性淋巴瘤提供了有前途的治疗方法.
- 免疫效应细胞相关神经毒性综合征 (ICANS) 是CAR T细胞疗法的显著剂量限制毒性.
- 临床前研究表明,阿纳金拉是一种IL-1受体对抗剂,可以在不影响CAR T细胞功能的情况下减轻ICANS.
研究的目的:
- 评估预防性阿纳金拉在治疗抗CD19CART细胞治疗的患者中减少严重ICANS的疗效.
- 评估阿纳金拉对细胞因子释放综合征 (CRS) 和整体疾病反应的影响.
- 确定anakinra在这个患者群体中的安全性和耐受性.
主要方法:
- 进行了一项2期临床试验,涉及复发/耐药的大B细胞和地幔细胞淋巴瘤的患者.
- 患者从第二天开始接受皮下阿纳金拉,至少在CAR T细胞输液后的第10天.
- 主要终点:严重的发病率 (等级≥3) ICANS. 二级终点:所有级别的CRS和ICANS,整体反应率.
主要成果:
- 在31名患者中,9.7%的患者经历了严重的ICANS,没有4级或5级事件.
- 所有级别的ICANS发生在19%的患者中.
- 严重的细胞因子释放综合征 (CRS) 发生在6.4%的患者中,整体疾病反应率为77% (65%的完整反应).
结论:
- 预防性阿纳金拉在接受抗CD19CAR T细胞治疗淋巴瘤的患者中显示出严重ICANS的发病率较低.
- 阿纳金拉似乎不会影响CAR T细胞治疗的抗淋巴瘤疗效.
- 这些发现支持进一步调查anakinra用于管理与免疫相关的神经毒性综合征.
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