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RecruitingPhase 2NCT07015242

A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma

The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Enrollment

65 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing lisocabtagene maraleucel (liso-cel), a personalized immune cell therapy (CAR-T therapy) where your own immune cells are modified to fight cancer, as a first-line treatment for adults with primary central nervous system (CNS) lymphoma — a rare brain tumor — who are not candidates for stem cell transplant. **You may be eligible if...** - You are 18 or older with confirmed primary CNS lymphoma - You are not a candidate for stem cell transplant (typically due to age 65+ or significant other health conditions) - Your lymphoma responded to prior high-dose methotrexate-based treatment - Your general health is adequate (ECOG 0–2) **You may NOT be eligible if...** - Your CNS lymphoma is secondary (spread from lymphoma elsewhere in the body) - You have had prior CAR-T or gene therapy - You have another active cancer not in remission for at least 2 years - You have a serious uncontrolled medical condition Talk to your doctor to see if this trial is right for you.

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

DRUGRituximab

Specified dose on specified days

DRUGMethotrexate

Specified dose on specified days

DRUGProcarbazine

Specified dose on specified days

DRUGTemozolomide

Specified dose on specified days

BIOLOGICALLiso-cel

Specified dose on specified days

DRUGFludarabine

Specified dose on specified days

DRUGCyclophosphamide

Specified dose on specified days

DRUGCalcium folinate

Specified dose on specified days

Locations(40)

University Of Colorado

Aurora, Colorado, United States

Moffitt Cancer Center

Tampa, Florida, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Local Institution - 0111

Nice, Alpes-Maritimes, France

Local Institution - 0104

Nantes, Loire-Atlantique, France

Local Institution - 0103

Pierre-Bénite, Rhône, France

Local Institution - 0106

Dijon, France

Local Institution - 0113

Lille, France

Local Institution - 0112

Marseille, France

CHU Montpellier

Montpellier, France

Local Institution - 0114

Paris, France

Local Institution - 0102

Paris, France

Local Institution - 0108

Pessac, France

CHU de Rennes - Hopital de Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

Local Institution - 0110

Saint-Cloud, France

Local Institution - 0115

Strasbourg, France

Local Institution - 0109

Toulouse, France

Local Institution - 0116

Vandœuvre-lès-Nancy, France

Local Institution - 0202

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Local Institution - 0207

Göttingen, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Klinikum Stuttgart - Katharinenhospital

Stuttgart, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT07015242

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