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

NCT07570862

This study is recruiting at 12 US sites in 5 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

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

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
12 to 70 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Fate Therapeutics
Last updated on ClinicalTrials.gov
September 14, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 5

  • Wallace Rheumatic Studies Center · Beverly Hills, CA
  • Kaiser Permanente Fontana · Fontana, CA
  • Providence Medical Foundation · Fullerton, CA
  • University of California Irvine · Irvine, CA
  • University of California San Francisco · San Francisco, CA

Florida · 4

  • GNP Research · Cooper City, FL
  • University of Florida Clinical Research Center · Gainesville, FL
  • Miami Dermatology and Laser Research · Miami, FL
  • Nicklaus Children's Hospital · Miami, FL

Nebraska · 1

  • University of Nebraska Medical Center · Omaha, NE

North Carolina · 1

  • Cross Creek Medical Clinic · Fayetteville, NC

Texas · 1

  • The University of Texas Southwestern Medical Center · Dallas, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.