FDA grants fast track designation to ALLO-329 for the treatment of systemic lupus erythematosus

On April 7, 2025, the U.S. FDA granted fast track designation to ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T-cell product, for the treatment of active refractory moderate-to-severe systemic lupus erythematous (SLE).¹ ALLO-329 utilizes technology that allows for reduction or elimination of the need for lymphodepletion.¹ 

Fast track designations were also granted in active severe/refractory idiopathic inflammatory myopathy (IIM), and active refractory diffuse systemic sclerosis (SSc).¹ A phase I trial, RESOLUTION, will be initiated in 2025 to evaluate the preliminary safety and efficacy of ALLO-329 in patients with SLE, IIM, and SSc. The trial will include two arms: one using cyclophosphamide alone for lymphodepletion, and the other involving no lymphodepletion at all.¹