Actively Recruiting
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Led by Fate Therapeutics · Updated on 2026-05-22
244
Participants Needed
21
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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
- Diagnosed with moderate to severe active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria
- Requires at least two prior treatments that were ineffective
- 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 impairment of heart, lung, liver, or kidney function
- Recent or ongoing serious infections
- History of active or 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 29 days
Participants receive FT819 and other study drugs through intravenous infusions according to assigned regimens to treat B-cell mediated autoimmune disease.
Multiple visits for drug infusions and monitoring during treatment period
Duration - Up to approximately 2 years
Participants are monitored for safety, disease activity, and quality of life after treatment ends.
Periodic visits over 2 years for assessments
Trial Site Locations
Total: 21 locations
1
Wallace Rheumatic Center
Beverly Hills, California, United States, 90210
Actively Recruiting
2
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
3
University of California Irvine
Irvine, California, United States, 92868
Actively Recruiting
4
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, United States, 90027
Actively Recruiting
5
University of California San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
6
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
8
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
9
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
10
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
11
Montefiore Medical Center
New York, New York, United States, 10467
Actively Recruiting
12
Duke University Health System
Durham, North Carolina, United States, 27705
Actively Recruiting
13
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
14
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73019
Actively Recruiting
15
Jefferson Einstein Hospital Philadelphia
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
16
Regional One Health
Memphis, Tennessee, United States, 38103
Actively Recruiting
17
Hôpital La Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
18
Uppsala University
Uppsala, Uppland, Sweden, 752 37
Actively Recruiting
19
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M139WL
Actively Recruiting
20
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
21
University College of London Hospitals NHS Trust (UCLH)
London, United Kingdom, NW1 2PQ
Actively Recruiting
Research Team
F
Fate Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here