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

Purpose

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.

Conditions

  • Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
  • Idiopathic Inflammatory Myositis (IIM)
  • Systemic Sclerosis (SSc)
  • Systemic Lupus Erythematosus (SLE)

Eligibility

Eligible Ages
Between 12 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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).

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Regimen A (Single dose with AMP)
  • Drug: FT819
    FT819 will be administered as intravenous (IV) infusion at planned dose levels.
  • Drug: Fludarabine
    Fludarabine will be administered as an IV infusion at planned dose levels.
    Other names:
    • FLUDARA
  • Drug: Cyclophosphamide
    Cyclophosphamide will be administered as an IV infusion at planned dose levels.
    Other names:
    • CYTOXAN
  • Drug: Bendamustine
    Bendamustine will be administered as an IV infusion at planned dose levels.
Experimental
Regimen B (Single-dose without AMP, with background therapy)
  • Drug: FT819
    FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Experimental
Regimen C (Two-dose with AMP)
  • Drug: FT819
    FT819 will be administered as intravenous (IV) infusion at planned dose levels.
  • Drug: Fludarabine
    Fludarabine will be administered as an IV infusion at planned dose levels.
    Other names:
    • FLUDARA
  • Drug: Cyclophosphamide
    Cyclophosphamide will be administered as an IV infusion at planned dose levels.
    Other names:
    • CYTOXAN
  • Drug: Bendamustine
    Bendamustine will be administered as an IV infusion at planned dose levels.
Experimental
Regimen D (Two-dose without AMP, with background therapy)
  • Drug: FT819
    FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Experimental
Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)
  • Drug: FT819
    FT819 will be administered as intravenous (IV) infusion at planned dose levels.

Recruiting Locations

MetroHealth
Cleveland 5150529, Ohio 5165418 44109

More Details

Status
Recruiting
Sponsor
Fate Therapeutics

Study Contact

Fate Clinical Trials
858-875-1800
clinicaltrials@fatetherapeutics.com