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.

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.

• Authors: 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
• Journal: Bone marrow transplantation (Bone Marrow Transplant) Vol. 58 Issue 3 Pg. 288-294 (03 2023) ISSN: 1476-5365 [Electronic] England
• PMID: 36477110 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2022. The Author(s), under exclusive licence to Springer Nature Limited.

Chemical References

• Receptors, Chimeric Antigen
• relmacabtagene autoleucel
• Antigens, CD19

Topics

• Humans
• Receptors, Chimeric Antigen
• Lymphoma, Large B-Cell, Diffuse (therapy)
• Lymphoma, Follicular
• T-Lymphocytes
• Immunotherapy, Adoptive (methods)
• Antigens, CD19