在慢性淋巴细胞白血病和小淋巴细胞淋巴瘤 (TRANSCEND CLL 004) 中的利索卡巴丁基马拉:多中心,开放式,单臂,第2阶段研究
Tanya Siddiqi1, David G Maloney2, Saad S Kenderian3
1Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, USA.
Lancet (London, England)
|June 9, 2023
概括
在复发性或耐药性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤患者中,Lisocabtagene maraleucel (lysocel) 显示出显著的完整响应率. 这种CAR- T细胞疗法为患者提供了可行的选择,之前的布鲁顿氨酸激酶抑制剂和venetoclax治疗都失败了.
科学领域:
- 癌症学
- 免疫疗法
- 血液学
背景情况:
- 慢性淋巴细胞白血病 (CLL) 和小淋巴细胞淋巴瘤 (SLL) 患者在布鲁顿氨酸激酶 (BTK) 抑制剂和venetoclax失效后复发或耐药性疾病的治疗选择有限.
- 利索卡巴丁基马拉利克 (liso- cel) 是一种正在研究中的仿真抗原受体 (CAR) T 细胞疗法.
研究的目的:
- 评估利索- 细胞在复发或耐药的CLL/ SLL患者的疗效和安全性,这些患者在BTK抑制剂和venetoclax治疗中都出现了进展.
- 为了确定完全响应 (CR) 率在推的第2阶段剂量 (DL2) 里索细胞.
主要方法:
- TRANSCEND CLL 004是一项开放式,单臂,第一阶段的研究.
- 117名患者接受了两种剂量水平的溶血细胞输液;初级疗效分析集中在49名BTK抑制剂进展和venetoclax失败的剂量水平2 (DL2) 的患者.
- 主要终点是通过独立审查评估的CR率.
主要成果:
- 在DL2 (p=0.0006) 的初级疗效分析中,观察到18%的统计学上显著的CR率 (在49名患者中9名).
- 3级细胞因子释放综合征发生在9%的患者中,而3级神经事件发生在18%的患者中.
- 由于巨激活综合征发生了一例与治疗相关的死亡.
结论:
- 在复发性/ 耐药性CLL/ SLL患者群体中,lysocel显示出显著的疗效,诱导完全反应.
- 利索细胞的安全性是可控的,细胞因子释放综合征和神经事件的发生率是可控的.
- 对于已经耗尽其他治疗方法的CLL/ SLL患者来说,lysocel是一种有前途的治疗选择.
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