Adicet Bio’s CAR T-Cell Therapy for SLE Granted Fast Track Designation

The U.S. Food and Drug Administration has awarded fast track designation (FTD) to Adicet Bio’s novel allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy ADI-001 for adults with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. The regulatory action marks the second such designation for ADI-001 after it was granted FTD in June 2024 for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN).

Adicet Bio is currently testing the investigational ADI-001 across six autoimmune indications. In addition to SLE, patient enrollment is ongoing for a Phase I trial of the drug for the treatment of LN, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS). The trial was initiated in the first quarter of 2025, and enrollment initiation is projected to begin for a trial of ADI-001 in anti-neutrophil cytoplasmic autoantibody-associated vasculitis in the second half of 2025.

The trial has four separate cohorts, with LN and SLE patients in a cohort, SSc patients in a cohort, IIM and SPS patients in a cohort and AAV patients in a fourth cohort. Investigators will administer a single dose of ADI-001 to these patient populations. A dose-limiting toxicity window will last for 28 days, at which point investigators will assess response and safety, as well as during a follow up period on months three, six, nine, 12, 18 and 24.

The primary endpoints of the trial are assessments of the safety and tolerability of ADI-001, with secondary endpoints that include measurement of cellular kinetics, pharmacodynamics, autoantibody titer changes and appropriate disease activity scores for each of the conditions.