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

10 september 2026 uppdaterad av: Fate Therapeutics

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)

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a multicenter, phase 2 single-arm trial designed to evaluate the efficacy and safety of FT819 in participants with moderate-to-severe systemic lupus erythematosus (SLE) with Class III/IV lupus nephritis (LN) (with or without concomitant Class V involvement) refractory to at least 2 immunosuppressive therapies prior to trial intervention.

Participants will undergo a screening period of up to 28 days. Following screening, trial intervention will consist of bendamustine administration followed by a single dose of FT819. Efficacy, safety, and exploratory assessments will be conducted at predefined timepoints through Month 24 of post-treatment follow-up (PTFU). 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.

Efficacy and disease activity will be assessed using standard LN measures, including complete renal response (CRR) and PRR (partial renal response), as well as clinician-reported outcomes, such as the SLEDAI-2K, BILAG, and PGA, performed at specified timepoints.

Studietyp

Interventionell

Inskrivning (Beräknad)

53

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Natalie Shiff, MD

Studieorter

  • Förenta staterna
    • California
      • Beverly Hills, California, Förenta staterna, 90210
        • Rekrytering
        • Wallace Rheumatic Studies Center
      • Fontana, California, Förenta staterna, 92335
        • Rekrytering
        • Kaiser Permanente Fontana
      • Fullerton, California, Förenta staterna, 92835
        • Rekrytering
        • Providence Medical Foundation
      • Irvine, California, Förenta staterna, 92868
        • Rekrytering
        • University of California Irvine
      • San Francisco, California, Förenta staterna, 64110
        • Rekrytering
        • University of California San Francisco
    • Florida
      • Cooper City, Florida, Förenta staterna, 33024
        • Rekrytering
        • Gnp Research
      • Gainesville, Florida, Förenta staterna, 32610
        • Rekrytering
        • University of Florida Clinical Research Center
      • Miami, Florida, Förenta staterna, 33155
        • Rekrytering
        • Nicklaus Children's Hospital
      • Miami, Florida, Förenta staterna, 33133
        • Rekrytering
        • Miami Dermatology and Laser Research
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68105
        • Rekrytering
        • University of Nebraska Medical Center
    • North Carolina
      • Fayetteville, North Carolina, Förenta staterna, 28304
        • Rekrytering
        • Cross Creek Medical Clinic
    • Texas
      • Dallas, Texas, Förenta staterna, 75390
        • Rekrytering
        • The University of Texas Southwestern Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: FT819
FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CD19-targeted CAR regulated by the TRAC locus, given as a single IV infusion
Biologisk: FT819
Single Intravenous (IV) infusion of FT819 administered on Day 1

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Complete Renal Response (CRR) at Week 26
Tidsram: Week 26

Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria:

  • UPCR <0.5 g/g
  • Estimated glomerular filtration rate (eGFR) ≥85% of baseline or ≥60 mL/min/1.73 m2
  • No use of rescue therapy
Week 26

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CRR at Week 52
Tidsram: Week 52
Proportion of participants who achieve CRR at Week 52
Week 52
CRR at Week 104
Tidsram: Week 104
Proportion of participants who achieve CRR at Week 104
Week 104
Overall Renal Response
Tidsram: Up to approximately 2 years
Proportion of participants who achieve an overall renal response, defined as achievement of either CRR or partial renal response (PRR), evaluated at Week 26, Week 52, and Week 104
Up to approximately 2 years
Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104
Tidsram: Up to approximately 2 years

PRR is defined as achievement of all of the following:

  • ≥50% reduction in UPCr from baseline and to <3 g/g if baseline UPCr ≥3 g/g
  • eGFR ≥80% of baseline or ≥60 mL/min/1.73 m2
  • No use of rescue therapy
Up to approximately 2 years
Lupus Low Disease Activity State (LLDAS)
Tidsram: Up to approximately 2 years
Proportion of participants who achieve lupus low disease activity state (LLDAS) at Week 26, Week 52, and Week 104
Up to approximately 2 years
Definition of Remission in SLE (DORIS)
Tidsram: Up to approximately 2 years
Proportion of participants who achieve a definition of remission in SLE (DORIS) at Week 26, Week 52, and Week 104
Up to approximately 2 years
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Tidsram: Up to approximately 2 years
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (adults age ≥18 years) score at Week 26, Week 52, and Week 104
Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4)
Tidsram: Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4) at Week 26, Week 52, and Week 104
Up to approximately 2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Fate Therapeutics

Publikationer och användbara länkar

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Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 juli 2026

Primärt slutförande (Beräknad)

1 juli 2029

Avslutad studie (Beräknad)

31 januari 2030

Studieregistreringsdatum

Först inskickad

30 april 2026

Först inskickad som uppfyllde QC-kriterierna

30 april 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FT819-201

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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