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Recruiting NCT06581198

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

Phase II Interventional Lupus Erythematosus, Systemic Lupus Nephritis

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rapcabtagene autoleucel.
Who it may be relevant to
Registry conditions: Lupus Erythematosus, Systemic, Lupus Nephritis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Brazil, Czechia +18
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Open-label, Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus (SLE) or Active, Refractory Lupus Nephritis (LN).

Overview

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Interventions

  • Biological rapcabtagene autoleucel
    single infusion of rapcabtagene autoleucel

Primary outcome measures

  • Evaluate the efficacy of rapcabtagene autoleucel [Time frame: Week 24, Week 52]
Secondary outcome measures (7)
  • Percentage of participants achieving complete renal response (CRR) [Time frame: Week 52]
  • Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved [Time frame: Week 12 to Week 52]
  • PPercentage of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares) [Time frame: Week 12 to Week 52]
  • Annualized cumulative corticosteroids dose [Time frame: Week 52]
  • Percentage of participants who are negative for serological status [Time frame: Week 52]
  • FACIT-Fatigue score change from baseline [Time frame: Baseline to Week 52]
  • Maintained DORIS [Time frame: Week 52 to Week 76]

Eligibility criteria

Inclusion criteria

  • Men and women with SLE, aged >= 18 years and =< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
  • Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of >= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
  • Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus
  • SLEDAI-2K Criteria at screening: SLEDAI-2K score >= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome".
  • Inadequate response at screening to at least two therapies

Exclusion criteria

  • Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy
  • Inadequate organ function during screening and prior to randomization
  • History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization
  • Human immunodeficiency virus (HIV) positivity at screening.
  • Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.
  • Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 19 centers
  • University Of Alabama — Birmingham
  • Loma Linda University — San Bernardino
  • UCSF — San Francisco
  • UCSF — San Francisco
  • Sutter Health Network — San Pablo
  • Ann and Robert H Lurie Childs Hosp — Chicago
  • Northwestern University — Chicago
  • University Of Iowa — Iowa City
  • … and 11 more centers
Japan · 12 centers
  • Novartis Investigative Site — Sapporo
  • Novartis Investigative Site — Kobe
  • Novartis Investigative Site — Yokohama
  • Novartis Investigative Site — Sendai
  • Novartis Investigative Site — Suita
  • Novartis Investigative Site — Izumo
  • Novartis Investigative Site — Bunkyo Ku
  • Novartis Investigative Site — Bunkyo-ku
  • … and 4 more centers
Germany · 10 centers
  • Novartis Investigative Site — Stuttgart
  • Novartis Investigative Site — Frankfurt am Main
  • Novartis Investigative Site — Cologne
  • Novartis Investigative Site — Leipzig
  • Novartis Investigative Site — Jena
  • Novartis Investigative Site — Essen
  • Novartis Investigative Site — Lübeck
  • Novartis Investigative Site — Mainz
  • … and 2 more centers
France · 9 centers
  • Novartis Investigative Site — Bordeaux
  • Novartis Investigative Site — Clermont-Ferrand
  • Novartis Investigative Site — Marseille
  • Novartis Investigative Site — Nantes
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Strasbourg
  • Novartis Investigative Site — Toulouse
  • … and 1 more center
Italy · 9 centers
  • Novartis Investigative Site — Alessandria
  • Novartis Investigative Site — Ancona
  • Novartis Investigative Site — Genova
  • Novartis Investigative Site — Milan
  • Novartis Investigative Site — Milan
  • Novartis Investigative Site — Rozzano
  • Novartis Investigative Site — Pescara
  • Novartis Investigative Site — Pisa
  • … and 1 more center
Spain · 9 centers

Center list to be confirmed — check the primary protocol.

Brazil · 5 centers
  • Novartis Investigative Site — Salvador
  • Novartis Investigative Site — Barretos
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo
Czechia · 3 centers
  • Novartis Investigative Site — Olomouc
  • Novartis Investigative Site — Prague
  • Novartis Investigative Site — Prague
Israel · 3 centers
  • Novartis Investigative Site — Haifa
  • Novartis Investigative Site — Ramat Gan
  • Novartis Investigative Site — Tel Aviv
Netherlands · 3 centers
  • Novartis Investigative Site — Leiden
  • Novartis Investigative Site — Groningen
  • Novartis Investigative Site — Utrecht
South Korea · 3 centers

Center list to be confirmed — check the primary protocol.

Austria · 2 centers
  • Novartis Investigative Site — Graz
  • Novartis Investigative Site — Vienna
Hungary · 2 centers
  • Novartis Investigative Site — Debrecen
  • Novartis Investigative Site — Budapest
Taiwan · 2 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 2 centers

Center list to be confirmed — check the primary protocol.

Australia · 1 center
  • Novartis Investigative Site — Clayton
Denmark · 1 center
  • Novartis Investigative Site — Aarhus N
Norway · 1 center
  • Novartis Investigative Site — Oslo
Romania · 1 center

Center list to be confirmed — check the primary protocol.

Saudi Arabia · 1 center

Center list to be confirmed — check the primary protocol.

Singapore · 1 center

Center list to be confirmed — check the primary protocol.

Sweden · 1 center

Center list to be confirmed — check the primary protocol.

Switzerland · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06581198 · CYTB323J12201 · 2023-510150-17-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗