A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Recruiting · NCT06308978 · Interventional (participants receive a specific treatment) · Lead sponsor: Fate Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
12 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
21 locations listed across 11 US states.
- Wallace Rheumatic Center - Beverly Hills, California, United States
- Providence Medical Foundation - Fullerton, California, United States
- University of California Irvine - Irvine, California, United States
- Children's Hospital Los Angeles Division Of Rheumatology - Los Angeles, California, United States
- University of California San Francisco - San Francisco, California, United States
- University of Florida - Gainesville, Florida, United States
- Nicklaus Children's Hospital - Miami, Florida, United States
- University of Louisville - Louisville, Kentucky, United States
- University of Minnesota Medical School - Minneapolis, Minnesota, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Montefiore Medical Center - New York, New York, United States
- Duke University Health System - Durham, North Carolina, United States
- MetroHealth - Cleveland, Ohio, United States
- University of Oklahoma - Oklahoma City, Oklahoma, United States
- Jefferson Einstein Hospital Philadelphia - Philadelphia, Pennsylvania, United States
- Regional One Health - Memphis, Tennessee, United States
- Cambridge University Hospitals NHS Foundation Trust - Cambridge, United Kingdom
- University College of London Hospitals NHS Trust (UCLH) - London, United Kingdom
- Hôpital La Pitié Salpêtrière - Paris, France
- Manchester University NHS Foundation Trust - Manchester, Greater Manchester, United Kingdom
- Uppsala University - Uppsala, Uppland, Sweden