RightFit
RecruitingPhase 2

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

A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 days, 15 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will undergo a screening period of up to 28 days."
  • "Following completion of these scheduled assessments, participants will continue in long-term follow-up (LTFU) for up to 15 years after FT819 administration to monitor ongoing safety and survival."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe FT819 is and how well it works after bendamustine treatment. FT819 uses donor immune cells changed to target a protein called CD19. It is for people ages 12–70 with moderate-to-severe lupus kidney disease that has not responded to treatment, and it checks kidney response at 26 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 12–70 years old.
  • You have systemic lupus erythematosus (SLE), diagnosed using the study’s required guidelines.
  • A kidney tissue test shows class III or IV lupus nephritis (kidney disease caused by lupus), with or without class V.
  • You test positive for at least one of these immune proteins: ANA, anti-dsDNA, or anti-Smith.
  • Your lupus is active enough to meet the study’s required disease scores.
  • Your urine protein-to-creatinine ratio is at least 1 g/g, showing protein leaking into your urine.
  • Your kidney disease is moderate to severe, and the study doctor thinks it could improve.
  • Your lupus kidney disease has not responded to at least two medicines that lower immune system activity.

Who can't join

  • Your organs do not work well enough, or you have permanent organ damage that the study doctor thinks this treatment would not help.
  • An autoimmune disease caused active brain or spinal cord symptoms within the past 12 months.
  • You have another kidney disease that could affect how the study doctor measures your lupus kidney disease.
  • You received dialysis, a treatment that filters waste from the blood, within 12 weeks before study treatment.
  • You have had cancer within the past 5 years.
  • You are allergic to human albumin or DMSO in FT819, or you cannot safely receive bendamustine.
  • You weigh less than 30 kg (about 66 pounds).
  • The study team believes a health problem, lab result, or personal or social issue could make participation unsafe, prevent you from following study rules, or affect the study results.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (12)

CA

FL

NC

NE

TX