FT819 in Lupus Nephritis: a targeted cell therapy trial for moderate-to-severe LN

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, open-label, single-arm study evaluating FT819 with a preceding bendamustine dose in participants with refractory proliferative lupus nephritis (Class III/IV with or without Class V). Eligible participants undergo screening, receive bendamustine followed by a single FT819 infusion, and are followed for up to 24 months of efficacy and safety assessments, plus long-term follow-up up to 15 years for safety and survival. Efficacy will be assessed using renal response measures (CRR/PRR) and SLE disease activity indices (SLEDAI-2K, BILAG, PGA). Key safety monitoring will capture treatment-emergent adverse events related to the intervention. The study will be conducted at several U.S. centers with Fate Therapeutics as the lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• Wallace Rheumatic Studies Center
  Beverly Hills, California, United States Recruiting
• Kaiser Permanente Fontana
  Fontana, California, United States Recruiting
• Providence Medical Foundation
  Fullerton, California, United States Recruiting
• University of California Irvine
  Irvine, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• GNP Research
  Cooper City, Florida, United States Recruiting

Study contacts

• Study coordinator: Fate Clinical Trials
• Email: clinicaltrials@fatetherapeutics.com
• Phone: 858-875-1800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.