On 2025‑10‑17, Adicet Bio, Inc. (NASDAQ: ACET) announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI‑001 in treatment‑refractory rheumatoid arthritis (RA). The study, which is now enrolling across seven autoimmune diseases, will assess two conditioning regimens—cyclophosphamide alone and cyclophosphamide combined with fludarabine—to determine how different preparatory treatments affect safety and therapeutic outcomes.
The primary objectives of the RA trial are safety and tolerability of ADI‑001, while secondary objectives include measuring cellular kinetics, pharmacodynamics, and disease‑activity scores. These endpoints align with the company’s broader Phase 1 program, which has already demonstrated favorable safety and B‑cell depletion in lupus nephritis and systemic lupus erythematosus and has received FDA Fast‑Track Designation for lupus nephritis, SLE, and systemic sclerosis.
This milestone advances ADI‑001 from pre‑clinical and early‑phase studies into active human testing, expanding the program’s reach to a seventh autoimmune indication and reinforcing the company’s regulatory momentum. The dosing event signals progress toward the anticipated 2H 2026 data release and positions Adicet to further validate its allogeneic gamma‑delta T‑cell platform across a spectrum of autoimmune diseases.
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