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

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

Summary

Eligibility
for people ages 12-70 (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends 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, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Systemic Scleroderma, Systemic Lupus Erythematosus, fludarabine, fludarabine phosphate, Cyclophosphamide, Bendamustine Hydrochloride, 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

  • UCSF accepting new patients
    San Francisco 5391959 California 5332921 94110 United States
  • Children's Hospital Los Angeles Division Of Rheumatology accepting new patients
    Los Angeles 5368361 California 5332921 90027 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
Contact us about this trial