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RECRUITINGPhase 2INTERVENTIONAL

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

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).

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 - Inyour organs (liver, kidneys, etc.) are working well enough based on blood tests 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 weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

rapcabtagene autoleucel

single infusion of rapcabtagene autoleucel

Locations (20)

University Of Alabama
Birmingham, Alabama, United States
Loma Linda University
San Bernardino, California, United States
UCSF
San Francisco, California, United States
UCSF
San Francisco, California, United States
Sutter Health Network
San Pablo, California, United States
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University Of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
WA Uni School Of Med
St Louis, Missouri, United States
Oregon Health Sciences University
Portland, Oregon, United States
Univ Of TX MD Anderson CC
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Vienna, Austria