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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Single Intravenous (IV) infusion of FT819 administered on Day 1
Complete Renal Response (CRR) at Week 26
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
Time frame: Week 26
CRR at Week 52
Proportion of participants who achieve CRR at Week 52
Time frame: Week 52
CRR at Week 104
Proportion of participants who achieve CRR at Week 104
Time frame: Week 104
Overall Renal Response
Proportion of participants who achieve an overall renal response, defined as achievement of either CRR or partial renal response (PRR), evaluated at Week 26, Week 52, and Week 104
Time frame: Up to approximately 2 years
Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104
PRR is defined as achievement of all of the following: * ≥50% reduction in UPCr from baseline and to \<3 g/g if baseline UPCr ≥3 g/g * eGFR ≥80% of baseline or ≥60 mL/min/1.73 m2 * No use of rescue therapy
Time frame: Up to approximately 2 years
Lupus Low Disease Activity State (LLDAS)
Proportion of participants who achieve lupus low disease activity state (LLDAS) at Week 26, Week 52, and Week 104
Time frame: Up to approximately 2 years
Definition of Remission in SLE (DORIS)
Proportion of participants who achieve a definition of remission in SLE (DORIS) at Week 26, Week 52, and Week 104
Time frame: Up to approximately 2 years
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (adults age ≥18 years) score at Week 26, Week 52, and Week 104
Time frame: Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4)
Proportion of participants who achieve SLE Responder Index-4 (SRI-4) at Week 26, Week 52, and Week 104
Time frame: Up to approximately 2 years
Natalie Shiff, MD
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