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.
Eligibility
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).
