Tundra Space

Book Demo Directory

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07015242

PHASE2

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

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

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2025-11-06

Completion Date

2028-12-10

Last Updated

2026-03-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rituximab

Specified dose on specified days

DRUG

Methotrexate

Specified dose on specified days

DRUG

Procarbazine

Specified dose on specified days

DRUG

Temozolomide

Specified dose on specified days

BIOLOGICAL

Liso-cel

Specified dose on specified days

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

DRUG

Calcium folinate

Specified dose on specified days

Inclusion Criteria * Participant must be 18 years or older at the time of signing the informed consent form (ICF). * Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology. * Transplant-ineligible based on physician's assessment and meeting at least one of the following criteria: age ≥65 years or HCT-CI (Hematopoietic Cell Transplantation-specific Comorbidity Index) score ≥3. * Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen. * Prior to signing ICF, anti-cancer therapy for the treatment of PCNSL must only include standard of care regimens, with or without corticosteroids given for disease-related symptoms. * Prior to ICF signature, participant's disease must be sensitive to prior high-dose methotrexate-based regimens, as demonstrated by a complete response (CR, no remaining signs of PCNSL) or a partial response (PR, signs of PNCSL mostly gone) per Investigator's assessment, based on the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention. Exclusion Criteria * Participant has a diagnosis of secondary CNS lymphoma due to systemic disease. * Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL) and isolated cerebrospinal fluid (CSF) disease. * Any significant medical condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she was to participate in the study based on investigator's judgement. * History of another primary malignancy that has not been in remission for ≥2 years. * Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology. * History of or active human immunodeficiency virus (HIV). * Active hepatitis B or active hepatitis C. * Active autoimmune disease requiring immunosuppressive therapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (82)

Local Institution - 307

Stanford, California, United States

Local Institution - 0305

Aurora, Colorado, United States

Local Institution - 305

Aurora, Colorado, United States

Local Institution - 308

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Local Institution - 0311

Chicago, Illinois, United States

Local Institution - 311

Chicago, Illinois, United States

Local Institution - 314

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Local Institution - 313

Boston, Massachusetts, United States

Local Institution - 316

St Louis, Missouri, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Local Institution - 0315

New Brunswick, New Jersey, United States

Local Institution - 315

New Brunswick, New Jersey, United States

Local Institution - 310

Buffalo, New York, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Local Institution - 301

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Local Institution - 302

Cleveland, Ohio, United States

Local Institution - 309

Columbus, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Local Institution - 304

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Local Institution - 312

Nashville, Tennessee, United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, United States

Local Institution - 0303

Houston, Texas, United States

Local Institution - 303

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Local Institution - 306

Seattle, Washington, United States

Local Institution - 0111

Nice, Alpes-Maritimes, France

Local Institution - 111

Nice, Alpes-Maritimes, France

Local Institution - 0104

Nantes, Loire-Atlantique, France

Local Institution - 104

Nantes, Loire-Atlantique, France

Local Institution - 0103

Pierre-Bénite, Rhône, France

Local Institution - 0106

Dijon, France

Local Institution - 106

Dijon, France

Local Institution - 0113

Lille, France

Local Institution - 113

Lille, France

Local Institution - 0112

Marseille, France

Local Institution - 112

Marseille, France

Local Institution - 0107

Montpellier, France

Local Institution - 107

Montpellier, France

Local Institution - 0114

Paris, France

Local Institution - 114

Paris, France

Local Institution - 0102

Paris, France

Local Institution - 102

Paris, France

Local Institution - 0108

Pessac, France

Local Institution - 108

Pessac, France

Local Institution - 103

Pierre-Bénite, France

CHU de Rennes - Hopital de Pontchaillou

Rennes, France

Local Institution - 101

Rennes, France

Local Institution - 0105

Rouen, France

Local Institution - 105

Rouen, France

Local Institution - 0110

Saint-Cloud, France

Local Institution - 110

Saint-Cloud, France

Local Institution - 0115

Strasbourg, France

Local Institution - 115

Strasbourg, France

Local Institution - 0109

Toulouse, France

Local Institution - 109

Toulouse, France

Local Institution - 0116

Vandœuvre-lès-Nancy, France

Local Institution - 116

Vandœuvre-lès-Nancy, France

Local Institution - 0202

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Local Institution - 205

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Local Institution - 0204

Cologne, North Rhine-Westphalia, Germany

Local Institution - 204

Cologne, North Rhine-Westphalia, Germany

Local Institution - 0206

Essen, North Rhine-Westphalia, Germany

Local Institution - 206

Essen, North Rhine-Westphalia, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Local Institution - 208

Chemnitz, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Local Institution - 203

Berlin, Germany

Local Institution - 202

Freiburg im Breisgau, Germany

Local Institution - 0207

Göttingen, Germany

Local Institution - 207

Göttingen, Germany

Local Institution - 209

Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Local Institution - 210

Heidelberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Klinikum Stuttgart - Katharinenhospital

Stuttgart, Germany

Local Institution - 201

Stuttgart, Germany