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

Last updated: April 8, 2025
Sponsor: Fate Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Dermatomyositis (Connective Tissue Disease)

Collagen Vascular Diseases

Systemic Lupus Erythematosus

Treatment

Fludarabine

Bendamustine

Cyclophosphamide

Clinical Study ID

NCT06308978
FT819-102
  • Ages 12-70
  • All Genders

Study 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 Criteria

Inclusion

Key Inclusion Criteria:

  • Age: 12 to 70 years old.

  • Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, orSSc) confirmed by standard criteria.

  • Disease Severity: Moderate to severe, requiring at least two prior treatments thatwere ineffective.

  • Health Status: Adequate organ function to tolerate treatment.

  • Consent: Able to provide informed consent or assent/obtain parental consent andcomply with study procedures.

Exclusion

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-celltherapy, or organ transplant.

  • Allergies: No known allergies to study treatments.

  • Weight Restriction: Must weigh at least 50 kg (110 lbs).

Study Design

Total Participants: 244
Treatment Group(s): 4
Primary Treatment: Fludarabine
Phase: 1
Study Start date:
March 28, 2024
Estimated Completion Date:
September 30, 2042

Connect with a study center

  • University of California Irvine

    Irvine, California 92868
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles Division Of Rheumatology

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • University of Minnesota Medical School

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

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