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

a study on Idiopathic Inflammatory Myositis (IIM) Systemic Sclerosis Lupus Diffuse Scleroderma Autoimmune Disease

Summary

Eligibility
for people ages 12-70 (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

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.

Keywords

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), FT819, Fate Therapeutics, Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), Allogeneic CAR-T, CD19-Targeted Therapy, Cell Therapy for Autoimmune Diseases, B-Cell Depletion in Autoimmune Disease, Phase 1 Clinical Trial, Allogeneic CAR cells, Autoimmune Diseases, A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases, Myositis, Vasculitis, Systemic Lupus Erythematosus, Systemic Scleroderma, Diffuse Scleroderma, Sclerosis, Cyclophosphamide, Bendamustine Hydrochloride, Fludarabine, Bendamustine

Eligibility

You can join if…

Open to people ages 12-70

  • 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.

You CAN'T join if...

  • 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).

Locations

  • University of California Irvine accepting new patients
    Irvine California 92868 United States
  • Children's Hospital Los Angeles Division Of Rheumatology accepting new patients
    Los Angeles California 90027 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha Nebraska 68198 United States
  • University of Minnesota Medical School accepting new patients
    Minneapolis Minnesota 55455 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fate Therapeutics
ID
NCT06308978
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 244 study participants
Last Updated