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以格菲妥单抗为基础的挽救治疗在中国复发/难治性侵袭性 B 细胞淋巴瘤患者中的真实世界疗效与安全性

英文原题:Real-World Efficacy and Safety of Glofitamab-Based Salvage Therapy in Chinese Patients With Relapsed or Refractory Aggressive B-Cell Lymphomas.

PubMed 2026/05/10(内容时间) Am J Hematol Q1 · IF 9.4(JCR 2025)

研究概要

这项观察性研究纳入 64 例 R/R 侵袭性 B 细胞淋巴瘤患者,他们在 2024 年 2 月至 2025 年 12 月期间于苏州大学附属第一医院接受了基于 glofitamab 的治疗。

中文摘要

CD20×CD3 双特异性抗体 glofitamab 已在复发或难治性(R/R)B 细胞淋巴瘤中显示显著疗效。然而,特别是在CAR-T 细胞治疗背景下,其真实世界临床表现及免疫学相关因素的数据仍有限。这项观察性研究纳入 64 名患者,他们于 2024 年 2 月至 2025 年 12 月在苏州大学附属第一医院接受 glofitamab 为基础的治疗,均患 R/R 侵袭性 B 细胞淋巴瘤。主要终点为完全缓解(CR)率,次要终点包括总缓解率(ORR)、无进展生存期(PFS)、总生存期(OS)及安全性。研究还分析既往双特异性抗体(BsAb)暴露对 CAR-T 细胞制备和疗效的影响,并评估外周 T 细胞亚群与治疗结局的关系。在 56 名可评估患者中,CR 率和 ORR 分别为 41.1% 和 78.7%。PFS 和 OS 中位数均未达到,估计 1 年 PFS 和 OS 率分别为 61.3% 和 67.7%。非生发中心 B 细胞(non-GCB)亚型患者的 PFS 显著高于 GCB 亚型(p=0.029),而既往接受 CAR-T 治疗与较差 PFS 相关(p=0.022)。既往 BsAb 暴露未影响 CAR-T 制备或疗效。免疫表型分析显示,达到 CR 的患者基线 CD4⁺效应 T 细胞计数较高(p=0.04),早期 CD8⁺ T 细胞扩增也更明显(p=0.02)。总体而言,glofitamab 在 R/R 侵袭性 B 细胞淋巴瘤中疗效持久且安全性可管理,治疗结局与 T 细胞功能状态密切相关,支持其作为 CAR-T 治疗前有效桥接策略的潜力。

展开英文摘要原文

Glofitamab, a CD20 CD3 bispecific antibody, has demonstrated significant efficacy in relapsed or refractory (R/R) B-cell lymphomas. However, real-world evidence on its clinical performance and immunologic correlates, particularly in the context of chimeric antigen receptor T-cell (CAR-T) therapy, remains limited. This observational study included 64 patients with R/R aggressive B-cell lymphoma who received glofitamab-based therapy between February 2024 and December 2025 at the First Affiliated Hospital of Soochow University. The primary endpoint was complete response (CR) rate, whereas secondary endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. We also analyzed the impact of prior bispecific antibody (BsAb) exposure on CAR-T cell manufacturing and efficacy and assessed the relationship between peripheral T-cell subsets and treatment outcomes. Among 56 evaluable patients, the CR and ORR were 41.1% and 78.7%, respectively. Median PFS and OS were not reached, with estimated 1-year PFS and OS rates of 61.3% and 67.7%. Patients with non-germinal center B-cell (non-GCB) subtype had significantly higher PFS than those with GCB subtype (p = 0.029), whereas prior CAR-T therapy was associated with poorer PFS (p = 0.022). Prior BsAb exposure did not affect CAR-T manufacture or efficacy. Immunophenotyping revealed that patients achieving CR had higher baseline CD4 + effector T-cell counts (p = 0.04) and higher early CD8 + T-cell expansion (p = 0.02). Overall, glofitamab demonstrated durable efficacy and a manageable safety profile in R/R aggressive B-cell lymphoma, with treatment outcomes closely associated with T-cell functional status, supporting its potential as an effective bridging strategy before CAR-T therapy.

论文信息

作者
Zhou J、Wang C、You T、Wang Y、Zong X、Wang Q、Chen W、Sheng K
单位
Department of Hematology, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.China
文献类型
观察性研究
期刊
American journal of hematology2026 Sep
原文标识
PubMed 42108795 · DOI 10.1002/ajh.70359