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...