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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Data availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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All funding is provided by JW Therapeutics (Shanghai) Co. Ltd.
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ZY: Patient enrollment, data acquisition, patient evaluation, and article preparation. YX, WZ, WL, NL, MT, XW, LP, LD, CZ, MW, FF, TD, YT: Patient enrollment and data acquisition. FS, ZG, JL: Project administration and supervision. YS: Data acquisition, statistical analysis, blood sample collection, patient evaluation, and article review. JZ: Project administration, patient enrollment, data acquisition, and article review.
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Ying, Z., Xie, Y., Zheng, W. et al. 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. Bone Marrow Transplant 58, 288–294 (2023). https://doi.org/10.1038/s41409-022-01888-z
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DOI: https://doi.org/10.1038/s41409-022-01888-z
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