Adicet Bio has dosed the first systemic sclerosis (SSc) subject in the Phase I trial’s second cohort evaluating the investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy, ADI-001, for autoimmune diseases.
The trial is currently enrolling subjects with SSc, lupus nephritis (LN), and systemic lupus erythematosus (SLE).
The Phase I trial comprises four separate arms, with LN and SLE subjects in one group, SSc subjects in another, idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) in the third, and adeno-associated virus (AAV) subjects in the fourth.
Participants who are enrolled will be given a dose of ADI-001, followed by a 28-day dose-limiting toxicity window.
Assessments for response and safety will take place on day 28, with further evaluations at three, six, nine, 12, 18, and 24-month follow-up periods.
The primary goals are to assess the tolerability and safety of the therapy. Secondary objectives are measurement of pharmacodynamics, cellular kinetics, changes in autoantibody titers, and disease activity scores specific to each indication.
Adicet Bio chief medical officer Julie Maltzman said: “There remains a critical unmet need for safe and effective treatment options to combat debilitating autoimmune diseases, including SSc, for which we believe ADI-001 has the potential to offer transformative benefits.
“We are pleased with the enrolment in our LN and SLE cohort and look forward to sharing preliminary clinical data from the trial in the second half of 2025.”
Said to target B-cells through an anti-CD20 CAR, ADI-001 has secured the US Food and Drug Administration’s (FDA) fast track status for the potential treatment of several conditions, including relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement, and SSc.
In the Phase I GLEAN trial, ADI-001 demonstrated the ability to target B-cells, showing strong exposure and complete CD19+ B-cell depletion in peripheral blood as well as secondary lymphoid tissue.
Last year, Adicet Bio initiated subject dosing in a multi-centre Phase I trial of ADI-270, a gamma delta CAR T-cell therapy, for the treatment of metastatic or advanced clear-cell renal cell carcinoma (ccRCC).
