Efficacy and safety of relmacabtagene autoleucel, an anti-CD19 chimeric antigen receptor T cell, in relapsed/refractory B-cell non-Hodgkin’s lymphoma: 2-year results of a phase 1 trial

IF 4.5 2区医学 Q1 HEMATOLOGY

Bone Marrow Transplantation Pub Date : 2022-12-07 DOI:10.1038/s41409-022-01888-z

Zhitao Ying, Yan Xie, Wen Zheng, Weiping Liu, Ningjing Lin, Meifeng Tu, Xiaopei Wang, Lingyan Ping, Lijuan Deng, Chen Zhang, Meng Wu, Feier Feng, Tingting Du, Yongjing Tang, Fang Su, Ziyu Guo, James Li, Yuqin Song, Jun Zhu

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引用次数: 1

Abstract

This study reported 2-year efficacy and safety of relma-cel in Chinese patients with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (B-NHL). In this phase 1 dose-escalating trial, patients received lymphodepleting chemotherapy for 3 days, followed by relma-cel as a single infusion in escalating dose levels (25 × 106, 50 × 106, 100 × 106, and 150 × 106 CAR-T cells). The endpoints included best objective response rate (ORR), best complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 23 patients were enrolled, including 60.9% with diffuse large B-cell lymphoma and 26.1% with follicular lymphoma. Twenty patients were evaluable for efficacy, and the best ORR was 85.0% and the best CRR was 75.0%. With a median follow-up of 24.2 months, 6 patients died and 2 had progressive disease, the median DOR, PFS, and OS were all not reached. The 2-year PFS and OS rates were 60.0% and 70.0%, respectively. Any grade and grade ≥ 2 cytokine release syndrome occurred in 18.2% and 13.6% of patients, respectively. Only 1(4.5%) patient had grade 3 CRS lasting 13 days, which was resolved by tocilizumab. No grade ≥ 2 neurotoxicity events or treatment-related deaths occurred. Patients with R/R B-NHL treated with relma-cel achieved durable response with favorable safety profile.

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抗 CD19 嵌合抗原受体 T 细胞 relmacabtagene autoleucel 治疗复发/难治性 B 细胞非霍奇金淋巴瘤的疗效和安全性：一期试验的两年结果

这项研究报告了relma-cel在中国复发/难治性（R/R）B细胞非霍奇金淋巴瘤（B-NHL）患者中2年的疗效和安全性。在这项1期剂量递增试验中，患者先接受为期3天的淋巴清除化疗，然后以递增剂量水平（25×106、50×106、100×106和150×106个CAR-T细胞）单次输注relma-cel。终点包括最佳客观反应率（ORR）、最佳完全反应率（CRR）、反应持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）和安全性。共有23名患者入组，其中弥漫大B细胞淋巴瘤患者占60.9%，滤泡性淋巴瘤患者占26.1%。20名患者接受了疗效评估，最佳ORR为85.0%，最佳CRR为75.0%。中位随访时间为24.2个月，6名患者死亡，2名患者病情进展，中位DOR、PFS和OS均未达标。2年的PFS和OS分别为60.0%和70.0%。分别有18.2%和13.6%的患者出现任何等级和≥2级细胞因子释放综合征。只有1例（4.5%）患者出现了持续13天的3级CRS，使用托西珠单抗后症状缓解。没有发生≥2级神经毒性事件或治疗相关死亡。接受relma-cel治疗的R/R B-NHL患者获得了持久的应答，且安全性良好。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bone Marrow Transplantation 医学-免疫学

CiteScore

8.40

自引率

8.30%

发文量

337

审稿时长

6 months

期刊介绍： Bone Marrow Transplantation publishes high quality, peer reviewed original research that addresses all aspects of basic biology and clinical use of haemopoietic stem cell transplantation. The broad scope of the journal thus encompasses topics such as stem cell biology, e.g., kinetics and cytokine control, transplantation immunology e.g., HLA and matching techniques, translational research, and clinical results of specific transplant protocols. Bone Marrow Transplantation publishes 24 issues a year.