Gracell: China NMPA Clears IND Application For GC012F

(RTTNews) - Gracell Biotechnologies Inc. (GRCL) announced the Center for Drug Evaluation of China's National Medical Products Administration has cleared the company'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.

Following the U.S. FDA's clearance of IND application announced on Feb. 3, Gracell plans to initiate a Phase 1b/2 clinical trial in the U.S. in the second quarter of 2023.

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