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FT819-102

  • Status
    Accepting Candidates
  • Age
    12 Years - 70 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases.
Protocol number OCR46720
ClinicalTrials.gov ID NCT06308978
Phase Phase 1

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).

Lead researcher

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  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
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