Biotechnology company Adicet Bio Inc (Nasdaq: ACET) announced on Monday the first dosing of a lupus nephritis (LN) patient in its Phase 1 trial for ADI-001, an allogeneic gamma delta CAR T cell therapy targeting B-cells via an anti-CD20 CAR. The FDA has granted Fast Track Designation for ADI-001 in relapsed/refractory class III or IV LN.

The trial includes four patient groups: LN and systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS), and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV). Enrolled patients receive a single dose, with safety and efficacy evaluated at 28 days and follow-ups up to 24 months.

Early data for LN is expected in the first half of 2025, with broader enrollment beginning in early 2025.

Adicet Bio develops "off-the-shelf" gamma delta T cell therapies for autoimmune diseases and cancer, enhancing treatment durability and safety with engineered CAR T cells.