October 16, 2025 — Leads & Copy —
Menlo Park, CA — Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company, has dosed the first patient in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory rheumatoid arthritis (RA). The trial is enrolling across seven autoimmune conditions.
According to Julie Maltzman, M.D., Chief Medical Officer of Adicet Bio, dosing the first patient in the ADI-001 clinical study is an important milestone in the company’s Phase 1 program. The study is evaluating two conditioning regimens, cyclophosphamide alone and in combination with fludarabine, to explore how different conditioning regimens may impact the overall therapeutic experience. The company is encouraged by recent safety and efficacy results of ADI-001 in lupus nephritis and systemic lupus erythematosus, and its potential to transform outcomes across a range of autoimmune conditions.
The Phase 1 study is designed to evaluate the safety, tolerability and preliminary efficacy of ADI-001 in patients with treatment-refractory RA, using two conditioning regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. The primary objectives are to evaluate the safety and tolerability of ADI-001, while secondary objectives include measuring cellular kinetics, pharmacodynamics, and disease activity scores.
Adicet Bio is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.
Contact:
Julie Maltzman, M.D., Chief Medical Officer of Adicet Bio.
Source: Adicet Bio, Inc.
