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在门诊环境中使用axicabtagene ciloleucel的可行性:前性试验的初级分析
Bhagirathbhai Dholaria1, Shakthi T Bhaskar2, Vivek G Patel2
1Department of Hematology-Oncology and Stem Cell Transplantation, Vanderbilt University Medical Center, Nashville, TN, USA. Bhagirathbhai.R.Dholaria@vumc.org.
Bone marrow transplantation
|March 25, 2025
概括
门诊使用axicabtagene ciloleucel (axi-cel) CAR-T疗法可用于扩散B细胞淋巴瘤. 这项试点研究使用了远程监测,显示了可控的副作用,并证实了门诊治疗的可行性.
科学领域:
- 在瘤学瘤学.
- 血液学 血液学 血液学
- 细胞疗法细胞疗法
背景情况:
- 嵌合式抗原受体 (CAR-T) 疗法的关键试验,包括 axicabtagene ciloleucel (axi-cel),主要用于住院患者.
- 复发性/耐药性扩散性B细胞淋巴瘤 (R/R DLBCL) 提出了挑战,需要创新的治疗方法.
研究的目的:
- 评估R/R DLBCL.在门诊环境中使用axi-cel的可行性和安全性.
- 评估在门诊轴细胞治疗期间使用可穿戴设备和远程医疗对患者持续远程监测的有效性.
主要方法:
- 进行了一个单中心,非随机,开放标签,前性临床试验 (NCT05108805).
- 20名R/R DLBCL患者在门诊中接受了轴细胞治疗.
- 持续的远程患者监测和远程医疗用于患者管理.
主要成果:
- 随访时间中位数为374天,患者年龄中位数为69岁.
- 在前4周内,有19名患者需要接受细胞因子释放综合征 (CRS) 管理.
- 2级CRS发生在40%的患者中;没有观察到3级或更高的CRS. 3级免疫效应细胞相关神经毒性综合征 (ICANS) 发生在20%的患者中;没有观察到4级或更高的ICANS. 没有发生与治疗相关的死亡.
结论:
- 对R/R DLBCL的外科患者给予轴细胞是可行的.
- 远程患者监测和远程医疗可以支持安全的门诊CAR-T治疗.
- 这种方法需要在更大的试验中进行进一步的调查.
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