ClinicaliQ Trial Snapshot
- A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease — Recruiting • Phase I • Cardiology / Cardiovascular • NCT06308978.
- What is being tested: FT819, a novel therapeutic agent targeting B-cell activity, is being evaluated for safety, pharmacokinetics, and anti-B-cell efficacy in patients with moderate-to-severe active systemic lupus erythematosus (SLE), with or without lupus nephritis.
- Patient eligibility overview: The trial enrolls adults with confirmed moderate-to-severe active SLE, including those with concurrent lupus nephritis, representing a population with significant unmet treatment needs and active autoimmune disease requiring intervention.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.