Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FT819 · 3 trials · 12 indications
Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria: * UPCR \<0.5 g/g * Estimated glomerular filtration rate (eGFR) ≥85% of baseline or ≥60 mL/min/1.73 m2 * No use of rescue therapy
The number of participants with TEAEs will be reported.
The number of participants with serious TEAEs will be reported.
The number of participants with DLTs will be reported.
| Arm | Type | Description |
|---|---|---|
| FT819 | EXPERIMENTAL | FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CD19-targeted CAR regulated by the TRAC locus, given as a single IV infusion |
| Regimen A (Single dose with AMP) | EXPERIMENTAL | - |
| Regimen B (Single-dose without AMP, with background therapy) | EXPERIMENTAL | - |
| Regimen C (Two-dose with AMP) | EXPERIMENTAL | - |
| Regimen D (Two-dose without AMP, with background therapy) | EXPERIMENTAL | - |
| Regimen B1 (Single-dose without AMP, background therapy temporarily suspended) | EXPERIMENTAL | - |
| FT819 Single-Dose Monotherapy, B-Cell Lymphoma | EXPERIMENTAL | FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma |
| FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma | EXPERIMENTAL | FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma |
| FT819 Step Fractionated Monotherapy, B-Cell Lymphoma | EXPERIMENTAL | FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma |
| FT819 Single-Dose Monotherapy, CLL | EXPERIMENTAL | FT819 single-dose monotherapy in adult subjects with r/r CLL |
| FT819 Single-Dose in Combination with IL-2, CLL | EXPERIMENTAL | FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL |
| FT819 Step Fractionated Monotherapy, CLL | EXPERIMENTAL | FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL |
| FT819 Single-Dose Monotherapy, B-ALL | EXPERIMENTAL | FT819 single-dose monotherapy in adult subjects with r/r B-ALL |
| FT819 Single-Dose in Combination with IL-2, B-ALL | EXPERIMENTAL | FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL |
| FT819 Step Fractionated Monotherapy, B-ALL | EXPERIMENTAL | FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL |
| FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma | EXPERIMENTAL | FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma |
| FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL | EXPERIMENTAL | FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL |
| FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL | EXPERIMENTAL | FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL |
| Name | Type | Description |
|---|---|---|
| FT819 | BIOLOGICAL | Single Intravenous (IV) infusion of FT819 administered on Day 1 |
| Fludarabine | DRUG | Fludarabine will be administered as an IV infusion at planned dose levels. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered as an IV infusion at planned dose levels. |
| Bendamustine | DRUG | Bendamustine will be administered as an IV infusion at planned dose levels. |
| IL-2 | DRUG | Biologic response modifier |
INCLUSION CRITERIA: * Age ≥12 to ≤70 years * Diagnosis of SLE per EULAR/ACR 2019 classification criteria * Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification * Positivity for at least one of the following au...
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FT819 is an investigational cell therapy being developed by Fate Therapeutics for B-cell mediated diseases and B-cell malignancies. It is designed to target CD19, a protein found on B cells, and is being studied in autoimmune conditions such as lupus nephritis and ANCA-associated vasculitis, as well as in B-cell lymphomas and leukemias.
FT819 targets CD19, an antigen expressed on the surface of B cells. By binding CD19, FT819 is intended to deplete B cells, which is the rationale for studying it in B-cell mediated autoimmune diseases and B-cell cancers. CD19 is a widely pursued antigen target in cell therapy development.
FT819 is being developed by Fate Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol FATE. Fate Therapeutics is the sponsor of the clinical trials evaluating FT819 in autoimmune disease and B-cell malignancies.
FT819 is in clinical development. It is being evaluated in Phase 1 studies in B-cell mediated autoimmune disease and in B-cell malignancies, and in a Phase 2 open-label trial in lupus nephritis. FT819 is investigational and has not been approved by the FDA.
FT819 is being studied in three registered trials. NCT06308978 is a Phase 1 study in B-cell mediated autoimmune disease, NCT07570862 is a Phase 2 open-label trial in lupus nephritis, and NCT04629729 is a Phase 1 study in B-cell malignancies. All three are listed as recruiting or active.
FT819 is being evaluated in lupus nephritis as an investigational treatment. A Phase 2 open-label, single-arm trial, NCT07570862, is studying FT819 in participants with lupus nephritis, including WHO Class III and Class IV disease, and is currently recruiting in the United States.