Gracell announces China NMPA clearance of IND application for trial of GC012F

Gracell Biotechnologies announced that the Center for Drug Evaluation , CDE, of China’s National Medical Products Administration, NMPA, has cleared Gracell’s Investigational New Drug, IND, application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus. Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate GC012F in rSLE patients. As announced Nov. 27, the Company will also commence Phase 1/2 clinical study in the U.S. An IIT is underway to evaluate GC012F for the treatment of rSLE. “This milestone marks our rapid progress in advancing development of GC012F in rSLE, an autoimmune disease with high unmet need,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell. “With an IIT well-underway and two IND studies planned in the U.S. and now China, we’re relentlessly pursing clinical development of an innovative CD19/BCMA dual-targeting approach, which seeks to offer differentiated efficacy over other investigational therapies that only target CD19.”