Gracell: China’s NMPA clears IND application for GC012F

Gracell Biotechnologies announced that the Center for Drug Evaluation of China’s National Medical Products Administration has cleared Gracell’s Investigational New Drug application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of relapsed/refractory multiple myeloma. Gracell plans to initiate a Phase 1/2, single-arm, open-label, multi-center trial in China in the third quarter of 2023 to further evaluate GC012F in RRMM patients. Following the U.S. FDA’s clearance of Gracell’s IND application announced on Feb. 3, Gracell also plans to initiate a Phase 1b/2 clinical trial in the U.S. in the second quarter of 2023.