Phase 1 Study of FT819 Treatment for Moderate to Severe B-cell Mediated Autoimmune Diseases Including Lupus, Vasculitis, Myositis, and Systemic Sclerosis

What this Trial Is About

Researchers are evaluating FT819, an investigational drug, in a phase 1 study for people aged 12 to 70 with moderate-to-severe active B-cell mediated autoimmune diseases. These conditions include systemic lupus erythematosus SLE with or without nephritis, antineutrophilic cytoplasmic antibody ANCA-associated vasculitis AAV, idiopathic inflammatory myositis IIM, and systemic sclerosis SSc. The study aims to assess the safety, how the drug is processed in the body, and its effect on B cells. The trial is sponsored by Fate Therapeutics and includes a dose-escalation stage followed by an expansion stage to further evaluate safety and activity. Participants will receive FT819 through intravenous IV infusion at planned dose levels. The study includes several treatment regimens, some using FT819 with an auxiliary medicinal product AMP and some without, combined with background therapies or temporarily suspending them. Other drugs such as fludarabine, cyclophosphamide, and bendamustine may also be administered as IV infusions at planned dose levels. The trial is non-randomized and open-label, with different dosing schedules including single or two-dose regimens. Participants will be closely monitored for treatment-emergent adverse events and dose-limiting toxicities up to approximately two years. Researchers will measure the plasma concentration of FT819, disease activity, and quality of life at designated time points. Safety assessments and evaluations of disease activity, including lupus nephritis when applicable, will be conducted throughout the study. The total participation time may extend up to two years to gather comprehensive safety and activity data.

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease