CARsgen Presents Updated Long-term Follow-up Results for Zevor-cel at IMS 2025

SHANGHAI, Sept. 17, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the updated long-term follow-up results of Phase I clinical trial of zevorcabtagene autoleucel (zevor-cel, R&D code: CT053, an autologous CAR T-cell product targeting BCMA) have been presented as a poster at the 22nd International Myeloma Society ("IMS") Annual Meeting. The poster was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" (Abstract number: PA-029).

In this study, a total of 14 patients with relapsed or refractory multiple myeloma (R/R MM) received a single infusion of zevor-cel. As of February 22, 2025, the median follow-up duration was 53.3 months (range:14.8, 63.5).

Regarding safety: There were no reports of ≥Grade 3 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), delayed neurotoxicities, second primary malignancy or other delayed AEs on the study.

Regarding efficacy: The overall response rate was 100% (95% CI: 76.8, 100.0) with 11 (78.6%) patients achieving complete response (CR) or stringent complete response (sCR). All patients who achieved CR or better were minimal residual disease (MRD) negative at 10⁻⁵ threshold. One patient remained in sCR at 59.3 months in the study. The median progression-free survival (mPFS) and the median duration of response (mDoR) were 44.1 months and 43.2 months in CR/sCR patients, respectively. The median overall survival (OS) was not reached. The proportion of patients surviving at 24, 36, 48 and 60 months after infusion were 100%, 92.3%, 84.6% and 76.9%, respectively.

At approximately 5 years of follow-up, zevor-cel demonstrates manageable safety profile while eliciting deep and durable responses in R/R MM patients.

About Zevor-cel

Zevor-cel is a fully human, autologous BCMA CAR T-cell product for the treatment of Multiple Myeloma (MM). Zevor-cel was approved by the NMPA on February 23, 2024 for the treatment of adult patients with R/R MM who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent). Zevor-cel received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019.

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.

Forward-looking Statements

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

SOURCE CARsgen Therapeutics