FT819 for Lupus Nephritis

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

Recruiting Phase 2 Interventional Study
Lupus Nephritis Systemic Lupus Erythematosus SLE - Systemic Lupus Erythematosus Lupus Nephritis - WHO Class III Lupus Nephritis - WHO Class IV
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
12 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
53 (estimated)
Sponsor
Fate Therapeutics · Industry
Who this trial is looking for

This trial is looking for people with lupus nephritis who have not responded well to previous treatments. Participants will receive a new therapy, FT819, to see if it helps improve kidney function over 26 weeks.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 12 and 70 years old.
  • I have been diagnosed with systemic lupus erythematosus (SLE).
  • I have a biopsy that shows Class III or IV lupus nephritis.
  • I have at least one positive autoantibody test.
  • I have signs of active lupus disease.
  • I have moderate-to-severe kidney disease.
  • I have not responded to at least two previous immunosuppressive treatments.

You may not be able to join if

  • I have poor organ function.
  • I have had active central nervous system symptoms in the last 12 months.
  • I have other kidney diseases that may affect the study.
  • I have received dialysis in the last 12 weeks.
  • I have irreversible organ damage from my disease.
  • I have had cancer in the past 5 years.
  • I am allergic to albumin or DMSO.
  • I cannot tolerate bendamustine.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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 au…
Contacts

Fate Clinical Trials

858-875-1800

clinicaltrials@fatetherapeutics.com

CONTACT

Natalie Shiff, MD

CONTACT