Adicet's T-Cell Therapy ADI-100 Fast Tracked by FDA for Refractory Systemic Lupus Erythematosus
Notably, the product previously received fast track designation from the FDA for relapsed/refractory class III or class IV lupus nephritis.
Adicet Bio’s ADI-100, its investigational allogeneic chimeric antigen receptor (CAR)-engineered gamma delta T-cell therapy being evaluated for the treatment of various autoimmune diseases, has received FDA fast track designation for refractory systemic lupus erythematosus (SLE) with extrarenal involvement.1
Notably, the product previously received fast track designation from the FDA for relapsed/refractory class III or class IV lupus nephritis (LN).1,2
The therapy, which targets the CD20 antigen, is currently being evaluated in a phase 1 clinical trial (NCT06375993) for patients with SLE, systemic sclerosis (SSc), antineutrophil cytoplasmic autoantibody associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS). ADI-001 is also being evaluated in the phase 1 GLEAN clinical trial (NCT04735471) for B-cell malignancies. In GLEAN, the CAR-T showed robust exposure and was able to bring about complete depletion of CD19+ B-cells in the peripheral blood and in secondary lymphoid tissue.
The phase 1 trial for autoimmune diseases dosed its first patient, who has LN, in November of last year. Adicet stated that it expects to begin enrolling patients with SLE, SSc, IIM, and SPS before the end of 2025's first quarter.3
The study has 4 arms, enrolling LN and SLE patients into 1 arm, SSc patients into a second arm, IIM and SPS in a third arm and AAV patients into a fourth arm. Enrolled patients will receive a single dose of ADI-001, with a dose-limiting toxicity window of 28 days.
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 appropriate disease activity scores in each indication.
“With clinical sites open for enrollment and additional sites that are expected to open in the near future, we anticipate sharing preliminary clinical data from the trial in the first half of 2025,” Francesco Galimi, MD, PhD, senior vice president and chief medical officer of Adicet Bio, said at the time of the dosing of the first patient.3
