CARsgen Therapeutics Holdings Limited (CARsgen) announced that the National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) clearance for CT0596, an allogeneic chimeric antigen receptor T-cell (CAR T-cell) therapy targeting B-cell maturation antigen (BCMA) for patients with relapsed or refractory multiple myeloma (R/R MM).

CT0596 was developed using CARsgen’s proprietary THANK-u Plus™ platform and is currently being assessed in investigator-initiated trials for R/R MM and plasma cell leukemia. Early clinical observations have indicated favorable tolerability and encouraging efficacy signals. CARsgen plans to extend clinical evaluation of CT0596 to additional plasma cell malignancies and autoimmune disorders driven by autoreactive plasma cells.

Preliminary data from the investigator-initiated trials were presented as a poster at the 2026 Annual Congress of the European Hematology Association, as disclosed on the company’s website.

CARsgen has established end-to-end capabilities covering target discovery, preclinical research, clinical development and commercial-scale production of CAR T-cell therapies aimed at hematologic malignancies, solid tumors and autoimmune diseases. The company emphasizes technology innovation to improve safety, enhance solid-tumor efficacy and lower treatment costs.

Under Hong Kong Listing Rule 18A.05, CARsgen notes that successful development or commercialization of CT0596 is not assured. Forward-looking statements in the announcement are subject to risks and uncertainties detailed in the company’s latest reports and disclosures.