NCT07570862
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
Recruiting · Phase 2 · Fate Therapeutics · registry updated 2026-09-14
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.
Inclusion
- 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 autoantibodies at screening:
- Antinuclear antibody (ANA)
- Anti-double-stranded DNA (anti-dsDNA) or
Exclusion
- Evidence of inadequate organ function during the screening period
- Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
- History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity
- Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
- Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant
- History of malignancy in the prior 5 years