US-based biopharmaceutical company Adicet Bio has begun enrolling patients in a Phase I clinical trial of ADI-001 to treat autoimmune diseases.
Enrolment in the trial began after the US Food and Drug Administration (FDA) awarded fast-track designation for ADI-001 to treat relapsed/refractory class III or class IV lupus nephritis (LN).
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The FDA also recently approved the drug’s development for LN, systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and ANCA-associated vasculitis (AAV).
The Phase I study is structured with three distinct arms, each enrolling subjects with different conditions.
Its first arm is enrolling LN and SLE patients, while the second arm is for SSc patients and the third will enrol AAV patients.
Participants in the trial will receive a single dose of ADI-001 and their response and safety will be assessed on day 28, as well as at three, six, nine, 12, 18 and 24 months into the follow-up period.
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By GlobalDataThe trial’s primary objective is to assess ADI-001’s safety and tolerability, while its secondary objectives are to measure the drug’s pharmacodynamics, cellular kinetics, variations in autoantibody titres and disease activity scores specific to each indication.
ADI-001 is an allogeneic gamma delta CAR-T cell therapy that targets B-cells through an anti-CD20 CAR.
Adicet Bio plans to report the initial clinical findings from this trial in the first half of next year.
Adicet Bio senior vice-president and chief medical officer Francesco Galimi said: “The favourable safety profile, cellular kinetics and B-cell depletion in peripheral blood and secondary lymphoid tissue demonstrated with ADI-001 clinical experience to date, positions ADI-001 to potentially bring a paradigm shift in the treatment of autoimmune diseases.
“We expect to have several additional sites open for enrolment by the end of the fourth quarter of 2024, and further increase the number of active sites during the first quarter of 2025.”
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