Allogene Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational allogeneic CAR-T therapy, ALLO-329, for three autoimmune conditions: active refractory moderate-to-severe systemic lupus erythematosus (SLE), active severe/refractory idiopathic inflammatory myopathies (IIM), and active refractory diffuse systemic sclerosis (SSc). The FDA designation also includes study of the therapy for active severe/refractory idiopathic inflammatory myopathy (IIM, an autoimmune disease that causes muscle weakness, inflammation and pain), specifically including dermatomyositis, immune mediated necrotizing myopathy, and antisynthetase syndrome; and active refractory diffuse systemic sclerosis (SSc).
The Phase 1 RESOLUTION trial is expected to launch mid-2025 and will also include people with lupus nephritis. The study will have two groups for lymphodepletion: one where participants will receive only cyclophosphamide for lymphodepletion, and another where no lymphodepletion regimen will be administered. The trial is designed to evaluate the safety and efficacy of ALLO-329 in people with SLE, IIM, and SSc.
ALLO-329 is an investigational allogenicCAR-T cell therapy. ALLO-329 targets both CD19+ B cells and CD70+ activated T cells. The therapy utilizes CRISPR-based specific integration to enable dual CAR expression and incorporates Allogene’s clinically validated Dagger® technology. This technology is aimed at minimizing or eliminating the need for lymphodepletion, a pre-treatment regimen which can pose a significant barrier to CAR-T cell therapy.
The proof-of-concept results from the RESOLUTION trial are anticipated by the end of 2025. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.
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