Adicet Bio, Inc. has announced the dosing of the first patient with lupus nephritis (LN) in a Phase 1 clinical trial evaluating ADI-001, an investigational allogeneic gamma delta CAR T cell therapy. This marks a significant step in the development of a potential off-the-shelf treatment for autoimmune diseases.
The Phase 1 study is designed with four separate arms, each targeting different autoimmune conditions. In addition to lupus nephritis, the trial will enroll patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS). Enrollment for these additional arms is expected to commence in the first quarter of 2025, with anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) patient enrollment expected in the second half of 2025.
ADI-001: A Novel Approach to Autoimmune Disease
ADI-001 is an allogeneic gamma delta CAR T cell therapy engineered to target B-cells via an anti-CD20 CAR. Preclinical data suggests that ADI-001 could offer a transformative approach by depleting B cells, which play a key role in the pathogenesis of various autoimmune disorders. The FDA has granted Fast Track Designation to ADI-001 for the treatment of relapsed/refractory class III or class IV lupus nephritis.
"Dosing the first lupus nephritis patient in our Phase 1 trial of ADI-001 marks an important step forward in our mission of improving the lives of patients affected by autoimmune diseases, particularly lupus nephritis," said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. He added, "With clinical biomarker data from our study in non-Hodgkin’s lymphoma demonstrating robust tissue trafficking and complete CD19+ B cell depletion in peripheral blood and secondary lymphoid tissue, ADI-001 has the potential to be a transformative off-the-shelf treatment option for several autoimmune diseases."
Trial Design and Objectives
In the Phase 1 trial, enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days, with response and safety assessments conducted on Day 28 and during the follow-up period at months 3, 6, 9, 12, 18, and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and relevant disease activity scores for each indication.
Anticipated Data and Future Enrollment
Adicet Bio anticipates sharing preliminary clinical data from the lupus nephritis arm of the trial in the first half of 2025. The company is actively opening clinical sites for enrollment and expects additional sites to become available soon.
Unmet Need in Autoimmune Diseases
The initiation of this trial addresses a significant unmet need in the treatment of autoimmune diseases. Lupus nephritis, a severe complication of systemic lupus erythematosus, affects a substantial portion of SLE patients and can lead to kidney failure and increased mortality. Current treatment options are often limited and may not provide adequate disease control for all patients.
Adicet Bio's ADI-001 represents a promising new avenue for therapeutic intervention in lupus nephritis and other autoimmune conditions. The company's approach leverages the unique properties of gamma delta T cells to target and eliminate B cells, potentially leading to durable remissions and improved outcomes for patients.
