A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
1 other identifier
interventional
244
4 countries
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2024
Longer than P75 for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
March 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2042
May 1, 2026
April 1, 2026
3.5 years
March 6, 2024
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with treatment-emergent adverse events (TEAEs)
The number of participants with TEAEs will be reported.
Up to approximately 2 years
Number of participants with serious TEAEs
The number of participants with serious TEAEs will be reported.
Up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
The number of participants with DLTs will be reported.
Up to approximately 29 days
Secondary Outcomes (4)
Plasma concentration of FT819
At designated time points up to approximately 29 days
Impact of treatment on quality of life
Up to approximately 2 years
Disease Activity
Up to approximately 2 years
Disease Activity in Participants with Lupus Nephritis
Up to approximately 2 years
Study Arms (5)
Regimen A (Single dose with AMP)
EXPERIMENTALRegimen B (Single-dose without AMP, with background therapy)
EXPERIMENTALRegimen C (Two-dose with AMP)
EXPERIMENTALRegimen D (Two-dose without AMP, with background therapy)
EXPERIMENTALRegimen B1 (Single-dose without AMP, background therapy temporarily suspended)
EXPERIMENTALInterventions
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine will be administered as an IV infusion at planned dose levels.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2024
First Posted
March 13, 2024
Study Start
March 28, 2024
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2042
Last Updated
May 1, 2026
Record last verified: 2026-04