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NCT07015242PHASE2Recruiting

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

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

Start Date

11/6/2025

Completion Date

12/10/2028

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 Criteria

Age Range: 18 years to No maximum

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 be limited to HD-MTX based standard of care regimens with a minimum of 4 and maximum of 6 doses of MTX. Corticosteroids used as part of standard-of-care management for PCNSL symptom control are permitted prior to ICF signature but must be discontinued at the time of ICF signature. For medical conditions other than PCNSL, non-therapeutic corticosteroids use may be permitted on study. * Prior to ICF enrollment, participant's disease must be sensitive to prior high-dose methotrexate-based (HD-MTX) 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), isolated cerebrospinal fluid (CSF) disease, or a relapsed or refractory PCNSL. * 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. * History of prior allogeneic transplant, or solid organ transplant requiring immunosuppressive therapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Rituximab

DRUG

Methotrexate

DRUG

Procarbazine

DRUG

Temozolomide

BIOLOGICAL

Liso-cel

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Calcium folinate

Interested in This Trial?

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Conditions

Lymphoma

Locations

University Of Colorado

Aurora, Colorado 80045

United States

Moffitt Cancer Center

Tampa, Florida 33612-9416

United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois 60611

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Washington University School of Medicine in St. Louis

St Louis, Missouri 63110-1010

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43202-2224

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Local Institution - 0111

Nice, Alpes-Maritimes 06202

France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, Loire-Atlantique 44093 Cedex 1

France

Local Institution - 0103

Pierre-Bénite, Rhône 69495

France

CHU de Dijon Bourgogne - Hopital Francois Mitterand

Dijon, 21079

France

Chru De Lille - Hopital Claude Huriez

Lille, 59037

France

Local Institution - 0112

Marseille, 13273

France

CHU Montpellier

Montpellier, 34295

France

Local Institution - 0114

Paris, 75010

France

Local Institution - 0102

Paris, 75013

France

Local Institution - 0108

Pessac, 33600

France

CHU de Rennes - Hopital de Pontchaillou

Rennes, 35033

France

Centre Henri Becquerel

Rouen, 79038

France

Local Institution - 0110

Saint-Cloud, 92210

France

Local Institution - 0115

Strasbourg, 67098

France

Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

Toulouse, 31059

France

Local Institution - 0116

Vandœuvre-lès-Nancy, 54500

France

Local Institution - 0202

Freiburg im Breisgau, Baden-Wurttemberg 79106

Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg 89070

Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia 50937

Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia 45147

Germany

Klinikum Chemnitz gGmbH

Chemnitz, Saxony 09116

Germany

Charité - Universitätsmedizin Berlin

Berlin, 12203

Germany

Local Institution - 0207

Göttingen, 37075

Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Klinikum Stuttgart - Katharinenhospital

Stuttgart, 70174

Germany