CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for CT071, an autologous CAR T-cell therapy candidate targeting G protein-coupled receptor class C group 5 member D (GPRC5D), for the treatment of patients with relapsed/refractory multiple myeloma (MM) or relapsed/refractory primary plasma cell leukemia (PCL).

GPRC5D is emerging as an important target in the landscape of MM, a common but incurable hematologic malignancy characterized by the uncontrolled proliferation of plasma cells. The notable overexpression of GPRC5D on the surface of malignant plasma cells, coupled with its limited presence on normal tissues, makes GPRC5D an ideal candidate for the treatment of MM and PCL. CT071 incorporates a fully-human single-chain variable fragment (scFV) developed by CARsgen, specifically designed to target GPRC5D.

CT071 is manufactured with CARsgen's proprietary CARcelerate^TM platform, which shortens the manufacturing time to less than 2 days and therefore yields younger, healthier, and possibly more potent CAR T cells compared to conventional manufacturing. The improved manufacturing efficiency also enhances the supply capacity, reduces the manufacturing costs, and expedites the availability of the product to the patients.

An investigator-initiated trial (IIT) is already under way in China to assess the safety and efficacy of CT071 in treating relapsed/refractory MM or PCL (NCT05838131). Preliminary clinical data from the IIT shows an acceptable safety profile with preliminary efficacy.