RecruitingPhase 1Phase 2NCT06121297

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

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

Sponsor

Cabaletta Bio

Enrollment

28 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus Lupus Nephritis

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CABA-201 and a biological treatment called CABA-201 for people with lupus nephritis and systemic lupus erythematosus. The study is currently recruiting participants at 23 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCABA-201

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

BIOLOGICALCABA-201

Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning

Locations(23)

University of California Irvine

Orange, California, United States

UC Davis Health

Sacramento, California, United States

Yale University

New Haven, Connecticut, United States

University of Florida Health

Gainesville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

UMass Memorial Hospital

Worcester, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

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NCT06121297

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