A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
Start Date
7/27/2026
Completion Date
1/31/2030
Summary
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.
Detailed 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 Criteria
Age Range: 12 years to 70 years
Interventions
FT819
Conditions
Locations
Wallace Rheumatic Studies Center
Beverly Hills, California 90210
United States
Kaiser Permanente Fontana
Fontana, California 92335
United States
Providence Medical Foundation
Fullerton, California 92835
United States
University of California Irvine
Irvine, California 92868
United States
University of California San Francisco
San Francisco, California 64110
United States
GNP Research
Cooper City, Florida 33024
United States
University of Florida Clinical Research Center
Gainesville, Florida 32610
United States
Miami Dermatology and Laser Research
Miami, Florida 33133
United States
Nicklaus Children's Hospital
Miami, Florida 33155
United States
University of Nebraska Medical Center
Omaha, Nebraska 68105
United States
Cross Creek Medical Clinic
Fayetteville, North Carolina 28304
United States
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States