A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Recruiting
Phase 1
Interventional Study
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
Idiopathic Inflammatory Myositis (IIM)
Systemic Sclerosis (SSc)
Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 12 – 70
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 244 (estimated)
- Sponsor
- Fate Therapeutics · Industry
Who this trial is looking for
This trial is looking for people between the ages of 12 and 70 who have certain autoimmune diseases that are not responding to previous treatments. They should generally be in good health, but not have serious heart or lung problems, active infections, or recent cancer. Also, women can't be pregnant or breastfeeding, and participants need to weigh at least 50 kg.
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About This Trial
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 …
Trial Locations
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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: Adequat…
Contacts