Allogene Therapeutics (ALLO) has received three FDA Fast Track Designations for ALLO-329, a next-generation dual-targeted CD19/CD70 allogeneic CAR T therapy. The designations cover treatments for systemic lupus erythematous (SLE), idiopathic inflammatory myopathy (IIM), and diffuse systemic sclerosis (SSc).
The company plans to initiate the Phase 1 RESOLUTION basket trial in mid-2025, with initial proof-of-concept expected by year-end 2025. The trial will evaluate ALLO-329's safety and preliminary efficacy using the proprietary Dagger® technology, which aims to reduce or eliminate lymphodepletion requirements. The study includes two lymphodepletion arms: one using cyclophosphamide alone and another without lymphodepletion.
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