CARsgen Therapeutics Holdings Limited announced that an abstract of zevorcabtagene autoleucel (" zevor-cel ", R&D code: CT053, an autologous CAR-T product candidate against BCMA) has been accepted as a poster presentation at the upcoming 2023 American Society of Hematology (the "ASH") Annual Meeting. Zevor-cel (CT053) is a fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. The New Drug Application (NDA) for zevor-cel is based on the Phase I/II data from LUMMICAR STUDY 1 in China which has been accepted by NMPA.

CARsgen is conducting a Phase 1b/2 LUMMICAR STUDY 2 clinical trial in North America to evaluate the safety and efficacy of zevor-cel for R/R MM. Zevor-cel received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019, as well as Priority Medicines (PRIME) and Orphan Medicinal Product designations from the European Medicines Agency (EMA) in 2019 and 2020, respectively. Zevor-cel also received Breakthrough Therapy designation from the NMPA in 2020.