REDWOOD CITY, Calif. — Adicet Bio, Inc. (Nasdaq: ACET), a clinical-stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory rheumatoid arthritis (RA). Preliminary data from the study are expected in the second half of 2026.
“Dosing the first patient in our clinical study of ADI-001 in treatment-refractory RA marks an important milestone in our Phase 1 program, which is now enrolling across seven autoimmune conditions,” said Julie Maltzman, M.D., Chief Medical Officer of Adicet Bio. “In this study we are evaluating two conditioning regimens, cyclophosphamide alone and in combination with fludarabine, to explore how different conditioning regimens may impact the overall therapeutic experience. Following the recent promising safety and efficacy results of ADI-001 in lupus nephritis and systemic lupus erythematosus, we are further encouraged about the potential of ADI-001 to transform outcomes across a range of autoimmune conditions.”
The Phase 1 trial in RA is designed to assess the safety, tolerability, and preliminary efficacy of ADI-001 in patients whose disease has not responded to standard treatments. The study will evaluate two conditioning regimens—cyclophosphamide alone and cyclophosphamide combined with fludarabine—and will measure cellular kinetics, pharmacodynamics, and disease activity scores as secondary endpoints.
ADI-001 is also being studied in a broader Phase 1 program targeting seven autoimmune diseases, including lupus nephritis, systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, ANCA-associated vasculitis, and rheumatoid arthritis. The U.S. Food and Drug Administration has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed or refractory class III or IV lupus nephritis, refractory systemic lupus erythematosus with extrarenal involvement, and systemic sclerosis.
The ongoing trial in RA is part of Adicet Bio’s larger initiative to develop a best-in-class portfolio of therapies for autoimmune diseases. The company is also advancing preclinical programs involving gene-edited and in vivo CAR T technologies targeting B cells, with the goal of reducing or eliminating the need for conditioning regimens in future treatments.
