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A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
NCT06308978 · Fate Therapeutics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
Key Inclusion Criteria:
* Age: 12 to 70 years old.
* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
* Health Status: Adequate organ function to tolerate treatment.
* Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.
Key Exclusion Criteria:
* Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
* Active Infections: No recent or ongoing serious infections.
* Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
* Allergies: No known allergies to study treatments.
* Weight Restriction: Must weigh at least 50 kg (110 lbs).
Study design
Enrollment target: 244 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-03-28
Estimated completion: 2042-09-30
Last updated: 2026-03-09
Interventions
Drug: FT819Drug: FludarabineDrug: CyclophosphamideDrug: Bendamustine
Primary outcomes
- • Number of participants with treatment-emergent adverse events (TEAEs) (Up to approximately 2 years)
- • Number of participants with serious TEAEs (Up to approximately 2 years)
- • Number of participants with dose-limiting toxicities (DLTs) (Up to approximately 29 days)
Sponsor
Fate Therapeutics · industry
Contacts & investigators
ContactFate Clinical Trials · contact · clinicaltrials@fatetherapeutics.com · 858-875-1800
All locations (17)
Providence Medical FoundationRecruiting
Fullerton, California, United States
University of California IrvineRecruiting
Irvine, California, United States
Children's Hospital Los Angeles Division Of RheumatologyRecruiting
Los Angeles, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
University of Minnesota Medical SchoolRecruiting
Minneapolis, Minnesota, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Montefiore Medical CenterRecruiting
New York, New York, United States
Duke University Health SystemRecruiting
Durham, North Carolina, United States
MetroHealthRecruiting
Cleveland, Ohio, United States
University of OklahomaRecruiting
Oklahoma City, Oklahoma, United States
Jefferson Einstein Hospital PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Regional One HealthRecruiting
Memphis, Tennessee, United States
Hôpital La Pitié SalpêtrièreRecruiting
Paris, France
Uppsala UniversityRecruiting
Uppsala, Uppland, Sweden
Manchester University NHS Foundation TrustRecruiting
Manchester, Greater Manchester, United Kingdom
Cambridge University Hospitals NHS Foundation TrustRecruiting
Cambridge, United Kingdom
University College of London Hospitals NHS Trust (UCLH)Recruiting
London, United Kingdom