A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Start Date
3/28/2024
Completion Date
9/30/2042
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 Criteria
Age Range: 12 years to 70 years
Interventions
FT819
Fludarabine
Cyclophosphamide
Bendamustine
Conditions
Locations
Wallace Rheumatic Center
Beverly Hills, California 90210
United States
Providence Medical Foundation
Fullerton, California 92835
United States
University of California Irvine
Irvine, California 92868
United States
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California 90027
United States
University of California San Francisco
San Francisco, California 94110
United States
University of Florida
Gainesville, Florida 32610
United States
Nicklaus Children's Hospital
Miami, Florida 33155
United States
University of Louisville
Louisville, Kentucky 40202
United States
University of Minnesota Medical School
Minneapolis, Minnesota 55455
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Montefiore Medical Center
New York, New York 10467
United States
Duke University Health System
Durham, North Carolina 27705
United States
MetroHealth
Cleveland, Ohio 44109
United States
University of Oklahoma
Oklahoma City, Oklahoma 73019
United States
Jefferson Einstein Hospital Philadelphia
Philadelphia, Pennsylvania 19141
United States
Regional One Health
Memphis, Tennessee 38103
United States
Hôpital La Pitié Salpêtrière
Paris, 75013
France
Uppsala University
Uppsala, Uppland 752 37
Sweden
Manchester University NHS Foundation Trust
Manchester, Greater Manchester M139WL
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
United Kingdom
University College of London Hospitals NHS Trust (UCLH)
London, NW1 2PQ
United Kingdom