Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults - PubMed

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Relmacabtagene autoleucel (relma-cel) is an anti-CD19 CAR-T therapy approved in China for certain lymphomas.
Phase 2 study evaluated relma-cel in 70 Chinese adults with relapsed/refractory mantle cell lymphoma (MCL).
59 patients received a single infusion of 100 × 10^6 CAR-positive T cells.
At 3 months, the objective response rate (ORR) was 71.19%, with a complete response rate of 59.32%.
Median duration of response (DOR) was 18.1 months, progression-free survival (PFS) was 15.5 months, and overall survival (OS) was 19.5 months.
Common grade 3 or higher adverse events included neutropenia (76.3%), leukopenia (69.5%), and lymphopenia (47.5%).
Severe cytokine release syndrome and neurotoxicity each occurred in 6.8% of patients, with all cases resolving fully.
No fatal events were reported.
Relma-cel demonstrated high response rates, durable remissions, and manageable safety in R/R MCL patients.

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