Lisocabtagene Maraleucel for Primary CNS Lymphoma in Transplant-Ineligible Patients
Rituximab
+ Methotrexate
+ Procarbazine
Hemic and Lymphatic Diseases+5
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: November 6, 2025
Actual date on which the first participant was enrolled.This study focuses on testing the safety and effectiveness of a new treatment called lisocabtagene maraleucel, also known as Breyanzi or liso-cel, for adults with a type of brain cancer called Primary Central Nervous System Lymphoma (PCNSL). This study is specifically for patients who cannot undergo a stem cell transplant. The goal is to see if this treatment can be used as a first-choice option for these patients, potentially improving their chances of recovery and offering new hope in treating this challenging condition. Participants in this study will receive the treatment directly, likely through an injection, as lisocabtagene maraleucel is a form of cell therapy. The study aims to carefully monitor how safe the treatment is for patients and how well it works in managing the cancer. While the study does not specify risks or benefits in detail, it is designed to gather important data on how patients respond to this treatment, which could lead to better treatment options in the future.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.65 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 82 locations
Dana-Farber Cancer Institute
Boston, United StatesWashington University School of Medicine in St. Louis
St Louis, United StatesRoswell Park Comprehensive Cancer Center
Buffalo, United States