CARsgen's BCMA CAR-T therapy zevor-cel approved in China

Shanghai-based CARsgen Therapeutics (HK: 2171) has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA).

The drug is approved for the treatment of adults with relapsed or refractory multiple myeloma who have previously progressed after at least three lines of therapy (including a proteasome inhibitor and immunomodulator agent).

Zevorcabtagene autoleucel is an autologous BCMA-targeted CAR T-cell product, generated by transducing T cells with a lentivirus encoding a CAR comprising a fully human BCMA-specific single chain variable fragment (scFv), the human CD8α hinge domain, CD8α transmembrane domain, 4-1 BB co-stimulatory domain and CD3ζ activation domain. The proprietary novel fully-human scFv has high binding affinity and stability.