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

Launched by JUNO THERAPEUTICS, INC., A BRISTOL-MYERS SQUIBB COMPANY · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called lisocabtagene maraleucel (often referred to as Liso-cel) for adults with a specific type of lymphoma called Primary Central Nervous System Lymphoma (PCNSL). This study is aimed at patients who cannot undergo a stem cell transplant, and it will assess how well this treatment works and its safety as a first-line therapy. The trial is not yet recruiting participants, but it will include adults aged 18 and older who meet certain criteria, such as having a confirmed diagnosis of PCNSL and being unsuitable for a stem cell transplant due to age or other health conditions.

To participate in the study, individuals must be able to handle a specific treatment regimen and have shown some response to prior therapies. They should not have other serious health issues or certain types of lymphoma that would affect their eligibility. If someone qualifies for the trial, they can expect to receive close monitoring and care throughout the process. This trial represents a hopeful option for those looking for new treatments for PCNSL, which can be challenging to manage.

Gender

ALL

Eligibility criteria

• 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.