A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Fate Therapeutics
244 participants
Mar 28, 2024
INTERVENTIONAL
Conditions
Summary
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active 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 will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine will be administered as an IV infusion at planned dose levels.
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT06308978