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...