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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07015242
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	France, Germany, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lymphoma
Study Website:	View Trial Website

Arms & Interventions