FT839 in Autoimmune Diseases

Part of paid clinical trials in Fullerton, California.

Sponsor
Fate Therapeutics
Study ID
NCT07800871
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • ANCA-Associated Vasculitis (AAV)
  • Idiopathic Inflammatory Myositis (IIM)
  • Rheumatoid Arthritis (RA)
  • Systemic Lupus Erythematosus (SLE)
  • Systemic Sclerosis (SSc)

Eligibility Criteria

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

Interventions

  • FT839 — BIOLOGICAL
    Single Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4

Study Details

The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy.

Key Dates

First listed
Sep 2, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2040

Study Design

Enrollment
446 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FT839 + Rituximab (Regimen A)
    FT839, allogeneic T cells targeting CD19 and CD38
  • Experimental: FT839 + Rituximab with stable background therapy (Regimen B)
    FT839, allogeneic T cells targeting CD19 and CD38
  • Experimental: FT839 monotherapy (Regimen C)
    FT839, allogeneic T cells targeting CD19 and CD38
  • Experimental: FT839 with stable background therapy (Regimen D)
    FT839, allogeneic T cells targeting CD19 and CD38
  • Experimental: Conditioning + FT839 + Rituximab (Regimen E)
    FT839, allogeneic T cells targeting CD19 and CD38
  • Experimental: Conditioning + FT839 + Rituximab with stable background therapy (Regimen F)
    FT839, allogeneic T cells targeting CD19 and CD38
  • Experimental: Conditioning + FT839 (Regimen G)
    FT839, allogeneic T cells targeting CD19 and CD38
  • Experimental: Conditioning + FT839 with stable background therapy (Regimen H)
    FT839, allogeneic T cells targeting CD19 and CD38

Primary Outcome Measure

Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events [ Time Frame: From enrollment to the end of the post-treatment follow-up at 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Medical FoundationFullertonCalifornia92835-

Find similar trials in Fullerton, CA

By research site
Providence Medical Foundation· Fullerton, CA

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