Gracell announces FDA clearance of IND application for Phase 1/2 trial

Gracell Biotechnologies announced that the U.S. Food and Drug Administration, FDA, has cleared Gracell’s Investigational New Drug, IND, application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus, rSLE. “We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell. “This progress marks the second U.S. IND clearance for GC012F, a notable milestone. As a next-generation CAR-T therapy, GC012F combines the innovative CD19/BCMA dual-targeting approach and our breakthrough FasTCAR next-day manufacturing technology, both of which could potentially provide meaningful benefits to SLE patients. Additionally, what sets GC012F apart is its consistently favorable safety profile demonstrated by the absence of neurotoxicity in 60 patients treated across three IIT studies. We look forward to developing GC012F as a transformative therapy for SLE patients, who are in urgent need of highly effective and safe treatment options.”