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Adicet Opens Enrollment for ADI-001 Phase 1 Clinical Trial in Autoimmune Diseases


Adicet Bio (Nasdaq: ACET) has opened enrollment for a Phase 1 clinical trial of ADI-001 in autoimmune diseases. The trial will focus on lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV). Enrollment is currently open for LN patients, with SLE, SSc, and AAV enrollment expected to begin in Q4 2024.

The FDA has granted Fast Track Designation to ADI-001 for relapsed/refractory class III or IV LN treatment. The Phase 1 study consists of three arms, with patients receiving a single dose of ADI-001. Primary objectives include evaluating safety and tolerability, while secondary objectives focus on cellular kinetics, pharmacodynamics, autoantibody titers, and disease activity scores.
Adicet anticipates reporting preliminary clinical data for all indications in the first half of 2025.
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