Allogene Therapeutics (NASDAQ:ALLO) announced that the FDA has granted three fast track designations (FTDs) for its ALLO-329, a next-generation dual-target CD19/CD70 allogeneic CAR T for the treatment of lupus, myositis, and scleroderma.
According to Allogene, the FDA designations follow recent investigational new drug (IND) application clearance for the RESOLUTION Basket Study of ALLO-329 in rheumatology. The launch of its Phase 1 REVOLUTION trial is planned for mid-2025 with proof-of-concept by the end of 2025.
In a statement, Zachary Roberts, MD, Ph.D., EVP of research and development and CMO of Allogene, said, “Receiving these designations for ALLO-329 underscores the versatility and transformative promise of this next-generation allogeneic CAR T investigational product in redefining the autoimmune treatment landscape. Leveraging our extensive expertise, we’ve developed this off-the-shelf CAR T specifically for autoimmune diseases, prioritizing both scalability and the reduction of elimination of lymphodepletion—a key barrier in this patient population.”
