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Clinical Trials in the UK / NCT06581198
Active, not recruiting Phase 2

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

NCT06581198 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2024-09-04
Last updated
2026-09-02

Condition(s) studied

Lupus Erythematosus, SystemicLupus Nephritis

Investigational drug(s) / intervention(s)

rapcabtagene autoleucel

rapcabtagene autoleucel: single infusion of rapcabtagene autoleucel

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key 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 Key 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.

Primary outcome measure(s)

Trial sites (107)

FacilityCityRegionStatus
University Of Alabama Birmingham Alabama
Loma Linda University San Bernardino California
UCSF San Francisco California
Sutter Health Network San Pablo California
Ann and Robert H Lurie Childs Hosp Chicago Illinois
Northwestern University Chicago Illinois
University Of Iowa Iowa City Iowa
University of Kentucky Lexington Kentucky
Tufts Medical Center Boston Massachusetts
Boston Medical Center Boston Massachusetts
WA Uni School Of Med St Louis Missouri
Duke Clinical Research Institute Durham North Carolina
James Cancer Hospital Columbus Ohio
Oregon Health Sciences University Portland Oregon
Houston Methodist Hospital Houston Texas
Univ Of TX MD Anderson CC Houston Texas
LDS Hospital Salt Lake City Utah
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Córdoba Córdoba Province
Novartis Investigative Site CABA Argentina
Novartis Investigative Site Clayton Victoria
Novartis Investigative Site Graz Austria
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Salvador Estado de Bahia
Novartis Investigative Site Curitiba Paraná
Novartis Investigative Site Barretos São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo Brazil
Novartis Investigative Site Olomouc Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Aarhus N Denmark
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Clermont-Ferrand France
Novartis Investigative Site Marseille France
Novartis Investigative Site Montpellier France
Novartis Investigative Site Nantes France
Novartis Investigative Site Paris France
Novartis Investigative Site Paris France

+ 67 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06581198 on ClinicalTrials.gov ↗ ← All trials in the UK