NCT07015242From ClinicalTrials.govRecruiting

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 Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

Lymphoma

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Enrolment target: 65
Started: 6 November 2025
Main results due: 9 January 2028
Study sites: 40
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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 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 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.
* No prior experimental treatments for PCNSL.
* 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), 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.

a. Exceptions include certain adequately treated non-invasive malignancies, localized prostate cancer treated with curative intent, and completely resected Stage 1 solid tumors with a low risk of recurrence.
* 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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(40)

University Of Colorado
Aurora, Colorado, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recruiting
Local Institution - 0111
Nice, Alpes-Maritimes, France
Not yet recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, France
Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
Recruiting
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon, France
Recruiting
Chru De Lille - Hopital Claude Huriez
Lille, France
Recruiting
Local Institution - 0112
Marseille, France
Not yet recruiting
CHU Montpellier
Montpellier, France
Recruiting
Local Institution - 0114
Paris, France
Not yet recruiting
Local Institution - 0102
Paris, France
Not yet recruiting
Local Institution - 0108
Pessac, France
Not yet recruiting
CHU de Rennes - Hopital de Pontchaillou
Rennes, France
Recruiting
Centre Henri Becquerel
Rouen, France
Recruiting
Institut Curie
Saint-Cloud, France
Recruiting
Local Institution - 0115
Strasbourg, France
Not yet recruiting
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
Toulouse, France
Recruiting
Local Institution - 0116
Vandœuvre-lès-Nancy, France
Not yet recruiting
Local Institution - 0202
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Not yet recruiting
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Recruiting
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Recruiting
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany
Recruiting
Universitätsmedizin Göttingen
Göttingen, Germany
Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Recruiting
Universitätsklinikum Heidelberg
Heidelberg, Germany
Recruiting
Klinikum Stuttgart - Katharinenhospital
Stuttgart, Germany
Recruiting

Showing 40 of 40 sites. 32 of the 40 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07015242. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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