RECRUITING

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

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Conditions

Lupus Erythematosus, SystemicLupus NephritisChimeric Antigen Receptor-T (CAR-T)rapcabtagene autoleucelLupus Nephritis (LN)Systemic Lupus Erythematosus (SLE)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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).

Quick Facts

Study Start:2024-09-04
Study Completion:2032-02-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06581198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus
  4. * 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".
  5. * Inadequate response at screening to at least two therapies
  1. * 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
  2. * Inadequate organ function during screening and prior to randomization
  3. * History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization
  4. * Human immunodeficiency virus (HIV) positivity at screening.
  5. * Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.
  6. * Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111
novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

UCSF
San Francisco, California, 94115
United States
UCSF
San Francisco, California, 94115
United States
Sutter Health Network
San Pablo, California, 94806
United States
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, 60611
United States
Northwestern University
Chicago, Illinois, 60611
United States
University Of Iowa
Iowa City, Iowa, 52242
United States
University of Kentucky
Lexington, Kentucky, 40536-0284
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States
Univ Of TX MD Anderson CC
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
LDS Hospital
Salt Lake City, Utah, 84143
United States
LDS Hospital
Salt Lake City, Utah, 84143
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-04
Study Completion Date2032-02-06

Study Record Updates

Study Start Date2024-09-04
Study Completion Date2032-02-06

Terms related to this study

Keywords Provided by Researchers

  • Chimeric Antigen Receptor-T (CAR-T)
  • rapcabtagene autoleucel
  • Lupus Nephritis (LN)
  • Systemic Lupus Erythematosus (SLE)

Additional Relevant MeSH Terms

  • Lupus Erythematosus, Systemic
  • Lupus Nephritis