Gracell: FDA clears IND application for Phase 1b/2 FasTCAR-T GC012F trial

Gracell Biotechnologies announced that the U.S. FDA has cleared Gracell’s Investigational New Drug application and the company can proceed to initiate a Phase 1b/2 clinical trial in the U.S. of GC012F, an autologous CAR-T therapeutic candidate, for the treatment of relapsed/refractory multiple myeloma. The company plans to initiate Phase 1b/2 clinical trial in the U.S. in second quarter of 2023.