RECRUITING Phase 2 ClinicalTrials.gov

A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis

Sponsor: Fate Therapeutics • ClinicalTrials.gov ID: NCT07570862

Registry updated: 2026-09-14

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Description

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.

Interventions

FT819 (Biological)
Single Intravenous (IV) infusion of FT819 administered on Day 1

Eligibility criteria

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 involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g/g; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible * Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN EXCLUSION CRITERIA: * 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 * Known allergy to the following FT819 components: albumin (human) or DMSO * History of intolerance or contraindication to bendamustine * Body weight \<30 kg * Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results

Conditions

Lupus Nephritis Systemic Lupus Erythematosus SLE - Systemic Lupus Erythematosus Lupus Nephritis - WHO Class III Lupus Nephritis - WHO Class IV

Locations

Wallace Rheumatic Studies Center — Beverly Hills, California, United States
Kaiser Permanente Fontana — Fontana, California, United States
Providence Medical Foundation — Fullerton, California, United States
University of California Irvine — Irvine, California, United States
University of California San Francisco — San Francisco, California, United States
GNP Research — Cooper City, Florida, United States
University of Florida Clinical Research Center — Gainesville, Florida, United States
Miami Dermatology and Laser Research — Miami, Florida, United States
Nicklaus Children's Hospital — Miami, Florida, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Cross Creek Medical Clinic — Fayetteville, North Carolina, United States
The University of Texas Southwestern Medical Center — Dallas, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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