China's Nod Granted to CARSGEN-B's BCMA-Targeting Universal CAR-T for Hard-to-Treat Myeloma

Stock News08-04 08:14

CARSGEN-B (02171) has announced that its universal CAR-T cell product, CT0596, which targets BCMA, has received Investigational New Drug (IND) approval from China's National Medical Products Administration. This clearance is for treating patients with relapsed/refractory multiple myeloma (R/R MM).

The results from CT0596's Investigator-Initiated Trial (IIT) were previously presented as a poster at the 2026 European Hematology Association (EHA) Annual Congress. CT0596 is a BCMA-targeting universal CAR-T cell therapy developed usingCARSGEN-B's proprietary THANK-u Plus™ platform. It is currently being evaluated in an IIT for R/R MM or plasma cell leukemia (PCL).

The therapy has shown an initial favorable safety profile and encouraging efficacy signals. The company also plans to further explore its potential in other plasma cell tumors and autoimmune diseases driven by autoreactive plasma cells.

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