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NCT07800871

FT839 in Autoimmune Diseases

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events
Timeframe: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Birmingham Vasculitis Activity Score
Timeframe: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Manual muscle testing-8
Timeframe: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Disease Activity Score using 28 joint counts and C-reactive protein (a composite measure)
Timeframe: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in SLE Disease Activity Index 2000
Timeframe: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Modified Rodnan skin score
Timeframe: From enrollment to the end of the post-treatment follow-up at 2 years

Secondary (4)

Phase 1: Maximum concentration and area under the curve of FT839 in peripheral blood
Phase 2: Incidence of AEs and SAEs
Phase 2: Cmax of FT839 in peripheral blood
Phase 2: AUC of FT839 in peripheral blood

Arms and interventions

FT839 + Rituximab (Regimen A)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

FT839 + Rituximab with stable background therapy (Regimen B)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

FT839 monotherapy (Regimen C)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

FT839 with stable background therapy (Regimen D)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

Conditioning + FT839 + Rituximab (Regimen E)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

Conditioning + FT839 + Rituximab with stable background therapy (Regimen F)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

Conditioning + FT839 (Regimen G)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

Conditioning + FT839 with stable background therapy (Regimen H)Experimental

FT839, allogeneic T cells targeting CD19 and CD38

Biologicals: FT839

Sites

1 site in 1 country

  • Providence Medical FoundationFullerton, California, United States