A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FT819, Fludarabine, Cyclophosphamide, Bendamustine.
- Who it may be relevant to
- Registry conditions: Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE). Basic parameters: 12 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Sweden, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels. - Drug Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels. - Drug Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels. - Drug Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Primary outcome measures
- Number of participants with treatment-emergent adverse events (TEAEs) [Time frame: Up to approximately 2 years]
- Number of participants with serious TEAEs [Time frame: Up to approximately 2 years]
- Number of participants with dose-limiting toxicities (DLTs) [Time frame: Up to approximately 29 days]
Secondary outcome measures (4)
- Plasma concentration of FT819 [Time frame: At designated time points up to approximately 29 days]
- Impact of treatment on quality of life [Time frame: Up to approximately 2 years]
- Disease Activity [Time frame: Up to approximately 2 years]
- Disease Activity in Participants with Lupus Nephritis [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- Wallace Rheumatic Center — Beverly Hills
- Providence Medical Foundation — Fullerton
- University of California Irvine — Irvine
- Children's Hospital Los Angeles Division Of Rheumatology — Los Angeles
- University of California San Francisco — San Francisco
- University of Florida — Gainesville
- Nicklaus Children's Hospital — Miami
- University of Louisville — Louisville
- … and 8 more centers
United Kingdom · 3 centers
- Manchester University NHS Foundation Trust — Manchester
- Cambridge University Hospitals NHS Foundation Trust — Cambridge
- University College of London Hospitals NHS Trust (UCLH) — London
France · 1 center
- Hôpital La Pitié Salpêtrière — Paris
Sweden · 1 center
- Uppsala University — Uppsala
Identifiers
NCT: NCT06308978 · FT819-102