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

Recruiting now · Phase 2

Conditions studied: Lymphoma

In brief

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).

Key facts

Study ID

NCT07015242

Run by

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

People needed

65

Starts

2025-11-06

Expected to finish

2028-12-10

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Klinikum Stuttgart - Katharinenhospital — Stuttgart, Germany (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• CHU de Rennes - Hopital de Pontchaillou — Rennes, France (enrolling)
• Centre Henri Becquerel — Rouen, France (enrolling)
• Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole — Toulouse, France (enrolling)
• Universitätsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany (enrolling)
• Universitätsklinikum Köln — Cologne, North Rhine-Westphalia, Germany (enrolling)
• Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany (enrolling)
• Klinikum Chemnitz gGmbH — Chemnitz, Saxony, Germany (enrolling)
• Charité - Universitätsmedizin Berlin — Berlin, Germany (enrolling)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (enrolling)
• University Of Colorado — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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