RECRUITING

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

Talk to us

Conditions

Systemic Lupus ErythematosusLupus NephritisCABA-201Autoimmune DiseaseAnti-CD19 CAR-T therapyCellular Therapy

Quick Navigation

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

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

Official Title

A Phase 1/2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus

Quick Facts

Study Start:2024-02-16
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06121297

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 and ≤65
  2. * A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE.
  3. * Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.
  4. * For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
  5. * For non-renal SLE subjects only: Active, moderate to severe SLE
  1. * Contraindication to leukapheresis
  2. * History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
  3. * Active infection requiring medical intervention at screening
  4. * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
  5. * Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
  6. * For LN subjects only: The presence of kidney disease other than active lupus nephritis
  7. * Previous CAR T cell therapy
  8. * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.

Contacts and Locations

Study Contact

Cabaletta Bio
CONTACT
267 759 3100
clinicaltrials@cabalettabio.com

Principal Investigator

Medical Director
STUDY_CHAIR
Cabaletta Bio

Study Locations (Sites)

University of California Irvine
Orange, California, 92868
United States
UC Davis Health
Sacramento, California, 95817
United States
Yale University
New Haven, Connecticut, 06520
United States
University of Florida Health
Gainesville, Florida, 32610
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Emory University
Atlanta, Georgia, 30322
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
UMass Memorial Hospital
Worcester, Massachusetts, 01655
United States
University of Minnesota
Minneapolis, Minnesota, 55414
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
University of Rochester
Rochester, New York, 14642
United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Cabaletta Bio

  • Medical Director, STUDY_CHAIR, Cabaletta Bio

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 Date2024-02-16
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-02-16
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • CABA-201
  • Autoimmune Disease
  • Anti-CD19 CAR-T therapy
  • Cellular Therapy
  • Systemic Lupus Erythematosus
  • Lupus Nephritis

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus
  • Lupus Nephritis