Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FT839 · 1 trial · 5 indications
Incidence and severity of dose-limiting Toxicity (DLT)s, adverse event (AE)s, and serious adverse event (SAE)s
Birmingham Vasculitis Activity Score (BVAS) will be measured to evaluate the efficacy of FT839 in AAV. The BVAS score ranges from 0 to 63, with lower scores indicating better outcomes.
Manual muscle testing-8 (MMT-8) will be measured to evaluate the efficacy of FT839 in IIM. The MMT-8 score ranges from 0 to 150, with higher scores indicating better outcomes.
Disease Activity Score using 28 joint counts and C-reactive protein (DAS28-CRP) will be measured to evaluate the efficacy of FT839 in RA. The validated composite measure DAS28-CRP score ranges from 0.0 to 9.4, with lower scores indicating better outcomes.
SLE Disease Activity Index 2000 (SLEDAI-2K) score will be measured to evaluate the efficacy of FT839 in SLE. The SLEDAI-2K score ranges from 0 to 105, with lower scores indicating better outcomes.
Modified Rodnan skin (mRSS) score will be measured to evaluate the efficacy of FT839 in SSc. The mRSS score ranges from 0 to 51, with lower scores indicating better outcomes.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| FT839 | BIOLOGICAL | Single Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4 |
Inclusion Criteria: * 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 * A...
FT839 is an investigational monoclonal antibody being developed for ANCA-Associated Vasculitis (AAV), a rare autoimmune disease. It is currently in Phase 1 clinical development and has not been approved by the FDA.
FT839 targets CD19 and CD38, which are cell surface markers. By targeting these proteins, the drug is designed to modulate immune cells involved in autoimmune diseases, though its precise mechanism is still under investigation.
FT839 is being developed by Fate Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol FATE. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
FT839 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is being studied in early-stage trials to assess its safety, tolerability, and dosing.
FT839 is being studied in a Phase 1 clinical trial with the identifier NCT07800871. This trial is currently recruiting participants and is designed to evaluate the drug in autoimmune diseases, including ANCA-Associated Vasculitis, with an enrollment target of 446 participants.
Yes, the Phase 1 trial for FT839 (NCT07800871) is also enrolling patients with Idiopathic Inflammatory Myositis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Systemic Sclerosis, in addition to ANCA-Associated Vasculitis.