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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

The CAROLYN Trial: Lisocabtagene Maraleucelas First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

NCT07015242•Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (82)

Local Institution - 307

Stanford, California, United States

Local Institution - 0305

Aurora, Colorado, United States

Local Institution - 305

Aurora, Colorado, United States

Local Institution - 308

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Local Institution - 0311

Chicago, Illinois, United States

Local Institution - 311

Chicago, Illinois, United States

Local Institution - 314

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Local Institution - 313

Boston, Massachusetts, United States

Key Dates

Start Date

November 6, 2025

Primary Completion Date

January 9, 2028

Completion Date

December 10, 2028

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

Lymphoma

Interventions

Rituximab

DRUG

Methotrexate

DRUG

Procarbazine

DRUG

Temozolomide

DRUG

Liso-cel

BIOLOGICAL

Fludarabine

DRUG

Cyclophosphamide

DRUG

Calcium folinate

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

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