#China #Shanghai #Multiple Myeloma #CARsgen #Zevor-cel

CARsgen Therapeutics Updates on Zevor-cel at IMS 2025

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) presented updated results from the Phase I clinical trial of its innovative CAR T-cell therapy, Zevor-cel, at the 22nd International Myeloma Society Annual Meeting in September 2025. These results showcase a notable advancement in the treatment of relapsed or refractory multiple myeloma (R/R MM), a disease characterized by its resistance to conventional therapies.

Background on Zevor-cel

Zevor-cel, known scientifically as zevorcabtagene autoleucel, is a fully human autologous CAR T-cell product specifically designed to target B-cell maturation antigen (BCMA). This therapy is intended for adult patients suffering from R/R MM whose condition continues to progress after at least three prior lines of treatment, which includes both a proteasome inhibitor and an immunomodulatory agent. The drug has received significant regulatory endorsements, including the Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug status from the U.S. FDA in 2019.

Study Overview

The presented research highlighted a cohort of 14 patients treated with a single infusion of Zevor-cel, with a median follow-up time of 53.3 months. The study was primarily aimed at evaluating the safety and efficacy profile of the treatment over an extended period.

Safety Profile

Impressively, the safety assessment revealed no occurrences of severe (>Grade 3) cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). Furthermore, there were no reported cases of delayed neurotoxicities, secondary malignancies, or other long-term adverse events related to the therapy.

Efficacy Results

The efficacy of Zevor-cel stood out with an overall response rate of 100%. Out of the 14 patients, 11 (78.6%) achieved either complete response (CR) or stringent complete response (sCR). Each patient who reached CR or better status tested negative for minimal residual disease (MRD) at a 10−5 threshold. Remarkably, one patient maintained stringent complete response for an astounding 59.3 months.

The median progression-free survival (mPFS) observed in CR/sCR patients was recorded at 44.1 months, while the median duration of response (mDoR) registered at 43.2 months. Notably, overall survival (OS) data has yet to reach a median outcome, but survival rates at 24, 36, 48, and 60 months post-infusion were impressive, recorded at 100%, 92.3%, 84.6%, and 76.9% respectively.

Conclusion

The updated findings presented at IMS 2025 reinforce Zevor-cel's potential as a safe and effective treatment option for patients with relapsed or refractory multiple myeloma, showing both durable clinical responses and a manageable safety profile. With the treatment now fully approved as of February 23, 2024, CARsgen Therapeutics aims to broaden the options available for patients battling this complex disease.

CARsgen remains dedicated to advancing CAR T-cell therapies, focusing on developing solutions tailored to meet the severe clinical demands, not only for hematologic malignancies but also for solid tumors and autoimmune disorders. The ongoing commitment of CARsgen is echoed in its continued investment in R&D capabilities and innovative therapeutic technologies designed to enhance patient outcomes worldwide.