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Brexucabtagene autoleucel 治疗亚洲复发/难治性套细胞淋巴瘤:重新定义异基因造血干细胞移植的作用

英文原题:Brexucabtagene autoleucel for relapsed/refractory mantle cell lymphoma in asia: redefining the role of allogeneic haematopoietic stem cell transplantation.

PubMed 2026/06/19(内容时间) Ann Hematol Q3 · IF 2.3(JCR 2025)

研究概要

在新加坡中央医院,5 例患者(中位年龄 75 岁)于 2025 年 4 月至 2025 年 12 月接受 brexu-cel 治疗 R/R MCL。

中文摘要

brexucabtagene autoleucel(brexu-cel)是一种自体CD19靶向CAR-T细胞疗法,基于关键性ZUMA-2试验获批用于复发/难治性(R/R)套细胞淋巴瘤(MCL)。此后,美国和欧洲多项真实世界研究显示其疗效相近。然而,这些报告也提示急性毒性可能更高,尤其是免疫效应细胞相关神经毒性综合征(ICANS),因此在脆弱人群中的应用引发担忧。2025年4月至12月,新加坡中央医院5例R/R MCL患者(中位年龄75岁)接受brexu-cel治疗。研究提取并比较本地既往接受异基因造血干细胞移植(allo-HSCT)的MCL患者队列。brexu-cel队列总缓解率(ORR)为100%,完全缓解率(CRR)为80%。细胞因子释放综合征(CRS)发生率为80%,无3级事件;仅1例患者出现1级ICANS(20%)。尽管brexu-cel患者基线可能具有更高危特征且疾病控制较差,其疗效和安全性结果仍优于本地既往allo-HSCT队列(共6例,其中2例复发、2例非复发死亡)。本文还总结了R/R MCL CAR-T临床试验和真实世界研究的疗效及毒性。据我们所知,这是亚洲首项R/R MCL brexu-cel真实世界报告,支持该疗法在本地区应用;迄今已发表数据主要来自美国和欧洲。

展开英文摘要原文

Brexucabtagene autoleucel (brexu-cel) is an autologous CD19-directed CAR T-cell therapy approved for relapsed/refractory (R/R) mantle cell lymphoma (MCL) based on the pilot study ZUMA-2. Since then, several US and European real-world studies have demonstrated comparable efficacy outcomes. However, these reports have also suggested potentially higher rates of acute toxicities, particularly immune effector cell-associated neurotoxicity syndrome (ICANS), raising concerns regarding its use, especially in vulnerable populations. At Singapore General Hospital, five patients (median age 75 years) received brexu-cel from April 2025 to Dec 2025 for R/R MCL. Historical cohort MCL patients received allogeneic haematopoietic stem cell transplantation (allo-HSCT) were extracted and compared. For brexu-cel cohort, the overall response rate (ORR) was 100%, with a complete response rate (CRR) of 80%. Cytokine release syndrome (CRS) occurred in 80% of patients, with no grade 3 events, and only one patient developed grade 1 ICANS (20%). These efficacy and safety outcomes compare favourably with historical cohorts of patients who underwent allo-HSCT locally (total 6 patients, 2 relapsed, 2 NRM), despite potentially higher-risk features and less controlled disease at baseline. Efficacy and toxicity of both clinical trial and real-world CAR-T studies for R/R MCL were summarized. To our knowledge, this represents the first real-world report from Asia on brexu-cel in R/R MCL, supporting its use in this region, where published data have thus far predominantly originated from the United States and Europe.

论文信息

作者
Ng LCK、Tan JY、Ong SY、Nagarajan C、Poon MLM、Ho AYL、Lim FWI、Chen Y
单位
Department of Haematology, Singapore General Hospital, Singapore, Singapore. lawrence.ng.c.k@singhealth.com.sg.Singapore
期刊
Annals of hematology2026 Jun 19
原文标识
PubMed 42319489 · DOI 10.1007/s00277-026-07126-6