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A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

RecruitingPhase 1Ages 12 Years - 70 YearsAllFate Therapeutics
NCT06308978 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • FT819
  • Fludarabine
  • Cyclophosphamide
  • Bendamustine
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Where

21 sites
Wallace Rheumatic Center
Beverly Hills, United States
Providence Medical Foundation
Fullerton, United States
University of California Irvine
Irvine, United States
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, United States
University of California San Francisco
San Francisco, United States
University of Florida
Gainesville, United States
Nicklaus Children's Hospital
Miami, United States
University of Louisville
Louisville, United States

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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