CARsgen Therapeutics Holdings Limited (HK:2171), a China-based company biopharmaceutical company focused on developing innovative CAR T-cell therapies, announced on Sunday that it has submitted two separate Investigational New Drug (IND) applications to China's National Medical Products Administration (NMPA) for its allogeneic BCMA-targeted CAR-T cell therapy product, CT0596.

The applications seek to initiate two corresponding Phase Ib/II clinical trials for the treatment of relapsed/refractory multiple myeloma (R/R MM) and primary plasma cell leukaemia (pPCL), respectively.

CT0596 is an allogeneic CAR T-cell therapy targeting BCMA, developed based on CARsgen's proprietary THANK-u Plus platform. The company says that through the knockout of genes such as NKG2A, TRAC, and B2M, CT0596 is designed to reduce the risk of graft-versus-host disease (GvHD) and host immune rejection. Additional gene editing further blocks host natural killer (NK) cell-mediated rejection, thereby aiming to enhance the product's efficacy and safety profile.

Investigator-initiated trials (IIT) for CT0596 have already been conducted in China to explore its clinical potential in treating R/R MM and pPCL. Data from the first-in-human study, presented at the 2025 American Society of Hematology (ASH) Annual Meeting, demonstrated a favourable safety profile and encouraging efficacy signals for CT0596.

The IND applications mark the start of the registration clinical development phase for CT0596, which holds the potential to offer a new treatment option for patients with R/R MM and pPCL.