Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07570862 | A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis | PHASE2 | NOT YET_RECRUITING | 53 | — | — | Jul 1, 2026 | Jan 31, 2030 | May 11, 2026 | - | — |
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
| 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 |
| Name | Type | Description |
|---|---|---|
| FT819 | BIOLOGICAL | Single Intravenous (IV) infusion of FT819 administered on Day 1 |
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...