用于复发或耐火性大B细胞淋巴瘤患者的利索卡巴丁基马拉利克尔 (TRANSCEND NHL 001):多中心无设计研究
Jeremy S Abramson1, M Lia Palomba2, Leo I Gordon3
1Massachusetts General Hospital Cancer Center, Boston, MA, USA.
Lancet (London, England)
|September 5, 2020
概括
在患有复发性或耐火性大B细胞淋巴瘤的患者中,利索卡巴丁烯maraleucel (lysocel) 显示出高响应率. 治疗显示出良好的安全性,严重的细胞因子释放综合征和神经事件的发生率较低.
科学领域:
- 血液学
- 癌症学
- 免疫疗法
背景情况:
- 利索卡巴基因马拉利克 (liso- cel) 是一种自主 CD19 导向的仿制抗原受体 (CAR) T 细胞疗法.
- 复发或耐药的大型B细胞淋巴瘤代表着一个重要的未满足的医疗需求.
研究的目的:
- 评估 liso- cel 在复发或耐受性大B细胞淋巴瘤的成年患者的疗效和安全性.
- 确定该患者群体中利索细胞的推剂量.
主要方法:
- 在14个美国癌症中心进行了无的1/ 2期研究.
- 患者接受了三种剂量之一的利索细胞 (50, 100, 或 150 x 10^6 CAR+ T细胞).
- 主要终点包括独立审查委员会评估的不良事件,剂量限制性毒性和客观反应率 (ORR).
主要成果:
- 其中269名患者接受了至少一剂利索细胞,其中中位数为前三次全身治疗.
- 推的目标剂量为100×10^6个CAR+T细胞.
- 客观反应率 (ORR) 为73%,完全反应率 (CR) 为53%.
- 最常见的不良事件是3级或更严重的中性质减退 (60%),贫血 (37%) 和血小板减退 (27%).
- 细胞因子释放综合征 (CRS) 和神经事件分别发生在42%和30%的患者中,其中3级或更严重事件的发生率较低 (2%为CRS,10%为神经毒性).
结论:
- 在患有复发性或耐火性大B细胞淋巴瘤的患者中,lysocel实现了高ORR和可控毒性.
- 具有较低严重CRS和神经事件的安全概况支持其使用.
- 利索塞尔是这一患者群体的一个有前途的治疗选择,目前正在进一步评估.
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