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

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.

Eligibility

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

Conditions6

Interventions1

Locations12 sites

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