An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age ≥18 to ≤70 years
• Must have active B-cell mediated autoimmune disease (AAV, IIM, RA, SLE, or SSc) confirmed by standard criteria
• Moderate to severe disease, requiring at least two prior treatments that were ineffective
• Adequate organ function to tolerate treatment
• Able to provide informed consent and comply with study procedures
Locations
United States
California
Providence Medical Foundation
RECRUITING
Fullerton
Contact Information
Primary
Fate Clinical Trials
clinicaltrials@fatetherapeutics.com
858-875-1800
Backup
Natalie Shiff, MD
Time Frame
Start Date: 2026-10
Estimated Completion Date: 2040-10
Participants
Target number of participants: 446
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Fate Therapeutics