Evaluating FT819 for autoimmune diseases
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
PHASE1 · Fate Therapeutics · NCT06308978
This study is testing a new treatment called FT819 to see if it can safely help people with moderate to severe autoimmune diseases feel better.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 12 Years to 70 Years |
| Sex | All |
| Sponsor | Fate Therapeutics (industry) |
| Drugs / interventions | CAR T |
| Locations | 18 sites (Fullerton, California and 17 other locations) |
| Trial ID | NCT06308978 on ClinicalTrials.gov |
What this trial studies
This phase 1 study aims to assess the safety, pharmacokinetics, and anti-B-cell activity of FT819 in patients with moderate to severe active autoimmune diseases, including systemic lupus erythematosus, ANCA-associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis. The study will involve a dose-escalation phase followed by an expansion phase to further evaluate the treatment's safety and efficacy. Participants will receive FT819, with or without auxiliary medicinal products, to determine the optimal dosing and therapeutic effects.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 70 with moderate to severe active B-cell mediated autoimmune diseases who have not responded to at least two prior treatments.
Not a fit: Patients with severe organ dysfunction, recent cancer, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat autoimmune diseases.
How similar studies have performed: While this approach is novel, similar studies targeting B-cell mediated autoimmune diseases have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Fullerton, California and 17 other locations
- Providence Medical Foundation — Fullerton, California, United States (RECRUITING)
- University of California Irvine — Irvine, California, United States (RECRUITING)
- Children's Hospital Los Angeles Division Of Rheumatology — Los Angeles, California, United States (RECRUITING)
- University of California San Francisco — San Francisco, California, United States (RECRUITING)
- University of Louisville — Louisville, Kentucky, United States (RECRUITING)
- University of Minnesota Medical School — Minneapolis, Minnesota, United States (RECRUITING)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)
- Montefiore Medical Center — New York, New York, United States (RECRUITING)
- Duke University Health System — Durham, North Carolina, United States (RECRUITING)
- MetroHealth — Cleveland, Ohio, United States (RECRUITING)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)
- Jefferson Einstein Hospital Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
- Regional One Health — Memphis, Tennessee, United States (RECRUITING)
- Hôpital La Pitié Salpêtrière — Paris, France (RECRUITING)
- Uppsala University — Uppsala, Uppland, Sweden (RECRUITING)
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (RECRUITING)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (RECRUITING)
- University College of London Hospitals NHS Trust (UCLH) — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Fate Clinical Trials
- Email: clinicaltrials@fatetherapeutics.com
- Phone: 858-875-1800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Antineutrophilic Cytoplasmic Antibody- Associated Vasculitis, Idiopathic Inflammatory Myositis, Systemic Sclerosis, Systemic Lupus Erythematosus, Lupus Nephritis, FT819, Fate Therapeutics, Idiopathic inflammatory myositis