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A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Sponsor: Fate Therapeutics
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), 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.
Key Details
Gender
All
Age Range
12 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
244
Start Date
2024-03-28
Completion Date
2042-09-30
Last Updated
2026-03-09
Healthy Volunteers
No
Conditions
Interventions
FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Locations (17)
Providence Medical Foundation
Fullerton, California, United States
University of California Irvine
Irvine, California, United States
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Montefiore Medical Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
MetroHealth
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Jefferson Einstein Hospital Philadelphia
Philadelphia, Pennsylvania, United States
Regional One Health
Memphis, Tennessee, United States
Hôpital La Pitié Salpêtrière
Paris, France
Uppsala University
Uppsala, Uppland, Sweden
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
University College of London Hospitals NHS Trust (UCLH)
London, United Kingdom