Actively Recruiting
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Led by Fate Therapeutics · Updated on 2026-05-01
244
Participants Needed
18
Research Sites
965 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 70 years old
- Confirmed diagnosis of active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) by standard criteria
- Moderate to severe disease requiring at least two prior ineffective treatments
- Adequate organ function to tolerate treatment
- Able to provide informed consent or assent with parental consent and comply with study procedures
You will not qualify if you...
- Pregnant or breastfeeding women
- Significant heart, lung, liver, or kidney dysfunction
- Recent or ongoing serious infections
- History of recent cancer, prior CAR T-cell therapy, or organ transplant
- Known allergies to study treatments
- Weight less than 50 kg (110 lbs)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
2
University of California Irvine
Irvine, California, United States, 92868
Actively Recruiting
3
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, United States, 90027
Actively Recruiting
4
University of California San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
5
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
7
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
8
Montefiore Medical Center
New York, New York, United States, 10467
Actively Recruiting
9
Duke University Health System
Durham, North Carolina, United States, 27705
Actively Recruiting
10
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
11
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73019
Actively Recruiting
12
Jefferson Einstein Hospital Philadelphia
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
13
Regional One Health
Memphis, Tennessee, United States, 38103
Actively Recruiting
14
Hôpital La Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
15
Uppsala University
Uppsala, Uppland, Sweden, 752 37
Actively Recruiting
16
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M139WL
Actively Recruiting
17
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
18
University College of London Hospitals NHS Trust (UCLH)
London, United Kingdom, NW1 2PQ
Actively Recruiting
Research Team
F
Fate Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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