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?
Review the details below, then apply to join this clinical trial.
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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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
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