A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)
Fate Therapeutics
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.
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 p…
Eligibility
- Age range
- 12–70 years
- Sex
- All
- Healthy volunteers
- No
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 autoantibodies at screening: 1. Antinuclear antibody (ANA) 2. Anti-double-stranded DNA (anti-dsDNA) or 3. Anti-Smith antibody * Active disease, defined as: a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ invo…