BOSTON — Adicet Bio, Inc. (Nasdaq: ACET) announced that the first patient with systemic sclerosis (SSc) has been dosed in its ongoing Phase 1 clinical trial evaluating ADI-001 for the treatment of autoimmune diseases. This marks a key milestone in the trial’s expansion to include multiple conditions, including lupus nephritis (LN), systemic lupus erythematosus (SLE), and now SSc.
“We are pleased with the continued momentum of our Phase 1 trial of ADI-001 in autoimmune diseases as we announce the dosing of the first SSc patient, a key development milestone for Adicet,” said Dr. Julie Maltzman, Chief Medical Officer of Adicet Bio. “There remains a critical unmet need for safe and effective treatment options to combat debilitating autoimmune diseases, including SSc, for which we believe ADI-001 has the potential to offer transformative benefits.”
The trial remains actively enrolling patients across all three indications, and the company expects to share preliminary clinical data in the second half of 2025.
ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy designed to target B-cells through an anti-CD20 chimeric antigen receptor. It has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory Class III or IV lupus nephritis, refractory SLE with extrarenal involvement, and systemic sclerosis.
