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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Fate Therapeutics
Study ID
NCT06308978
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • FT819 — DRUG
    FT819 will be administered as intravenous (IV) infusion at planned dose levels.
  • Fludarabine — DRUG
    Fludarabine will be administered as an IV infusion at planned dose levels.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as an IV infusion at planned dose levels.
  • Bendamustine — DRUG
    Bendamustine will be administered as an IV infusion at planned dose levels.

Study Details

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.

Key Dates

Start date
Mar 28, 2024
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2042

Study Design

Enrollment
244 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A (Single dose with AMP)
  • Experimental: Regimen B (Single-dose without AMP, with background therapy)
  • Experimental: Regimen C (Two-dose with AMP)
  • Experimental: Regimen D (Two-dose without AMP, with background therapy)
  • Experimental: Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 2 years ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Wallace Rheumatic CenterBeverly HillsCalifornia90210-
Providence Medical FoundationFullertonCalifornia92835-
University of California IrvineIrvineCalifornia92868-
Children's Hospital Los Angeles Division Of RheumatologyLos AngelesCalifornia90027-
University of California San FranciscoSan FranciscoCalifornia94110-
University of FloridaGainesvilleFlorida32610-
Nicklaus Children's HospitalMiamiFlorida33155-
University of LouisvilleLouisvilleKentucky40202-
University of Minnesota Medical SchoolMinneapolisMinnesota55455-
University of Nebraska Medical CenterOmahaNebraska68198-
Montefiore Medical CenterNew YorkNew York10467-
Duke University Health SystemDurhamNorth Carolina27705-
MetroHealthClevelandOhio44109-
University of OklahomaOklahoma CityOklahoma73019-
Jefferson Einstein Hospital PhiladelphiaPhiladelphiaPennsylvania19141-
Regional One HealthMemphisTennessee38103-

Find similar trials in Beverly Hills, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Wallace Rheumatic Center· Beverly Hills, CAProvidence Medical Foundation· Fullerton, CAUniversity of California Irvine· Irvine, CAChildren's Hospital Los Angeles Division Of Rheumatology· Los Angeles, CAUniversity of California San Francisco· San Francisco, CAUniversity of Florida· Gainesville, FL

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