NCT06308978 A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
| NCT ID | NCT06308978 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fate Therapeutics |
| Condition | Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 244 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2027-09-30 |
Trial Parameters
Eligibility Fast-Check
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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), 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).