A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Fate Therapeutics
244 participants
Mar 28, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria6
- 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).
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Interventions
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine will be administered as an IV infusion at planned dose levels.
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT06308978