A Phase 2 Trial of FT819 in Participants with Refractory Systemic Lupus Erythematosus with Lupus
Study Description
This is a multicenter, phase 2 single-arm trial designed to evaluate the efficacy and safety of FT819 in participants with moderate-to-severe systemic lupus erythematosus (SLE) with Class III/IV lupus nephritis (LN) (with or without concomitant Class V involvement) refractory to at least 2 immunosuppressive therapies prior to trial intervention.
Participants will undergo a screening period of up to 28 days. Following screening, trial intervention will consist of bendamustine administration followed by a single dose of FT819. Efficacy, safety, and exploratory assessments will be conducted at predefined timepoints through Month 24 of post-treatment follow-up (PTFU). Following completion of these scheduled assessments, participants will continue in long-term follow-up (LTFU) for up to 15 years after FT819 administration to monitor ongoing safety and survival.
Efficacy and disease activity will be assessed using standard LN measures, including complete renal response (CRR) and PRR (partial renal response), as well as clinician-reported outcomes, such as the SLEDAI-2K, BILAG, and PGA, performed at specified timepoints.
Eligibility
INCLUSION CRITERIA
- Age 12 to 70 years, inclusive.
- Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
- Biopsy-proven proliferative Class III or IV lupus nephritis (LN), with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification.
- Positive for at least one of the following autoantibodies at screening:
a. Antinuclear antibody (ANA).
b. Anti-double-stranded DNA (anti-dsDNA) antibody.
c. Anti-Smith antibody.
- Active disease meeting ALL of the following:
a. Evidence of SLE activity, defined as either a SLEDAI-2K score of at least 6 OR at least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement.
b. Evidence of renal involvement, defined as a urine protein-to-creatinine ratio (UPCr) of at least 1 g/g.
c. Moderate-to-severe renal disease that, in the investigator's opinion, has potential to improve.
- Lupus nephritis refractory to at least 2 systemic immunosuppressive therapies.
EXCLUSION CRITERIA
- Evidence of inadequate organ function during screening.
- Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months before trial intervention.
- History of or current renal disease other than lupus nephritis that, in the investigator's opinion, could interfere with assessment of lupus nephritis or confound evaluation of disease activity.
- Received dialysis (hemodialysis or peritoneal dialysis) within 12 weeks before trial intervention.
- Irreversible organ damage related to the underlying disease, such as end-stage renal disease (ESRD), for which the investigator considers CD19 CAR T-cell therapy unlikely to benefit the participant.
- History of malignancy within the prior 5 years.
- Known allergy to either of the following FT819 components: human albumin or dimethyl sulfoxide (DMSO).
- History of intolerance or contraindication to bendamustine.
- Body weight less than 30 kg.
- Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, in the investigator's or medical monitor's judgment, prevents safe participation in and completion of the trial, or could affect compliance with the protocol or interpretation of results.
