RecruitingRecruiting
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
NCT07015242 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
In plain English
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Official title
The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients
About this study
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 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.
Study design
Enrollment target: 65 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-06
Estimated completion: 2028-12-10
Last updated: 2026-09-01
Interventions
Drug: RituximabDrug: MethotrexateDrug: ProcarbazineDrug: TemozolomideBiological: Liso-celDrug: FludarabineDrug: CyclophosphamideDrug: Calcium folinate
Primary outcomes
- • Progression-free Survival (PFS) (12 months after liso-cel infusion)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (40)
University Of ColoradoRecruiting
Aurora, Colorado, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityRecruiting
Chicago, Illinois, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Washington University School of Medicine in St. LouisRecruiting
St Louis, Missouri, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute Oncology PartnersRecruiting
Nashville, Tennessee, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Local Institution - 0111Not Yet Recruiting
Nice, Alpes-Maritimes, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
Nantes, Loire-Atlantique, France
Local Institution - 0103Not Yet Recruiting
Pierre-Bénite, Rhône, France
CHU de Dijon Bourgogne - Hopital Francois MitterandRecruiting
Dijon, France
Chru De Lille - Hopital Claude HuriezRecruiting
Lille, France
Local Institution - 0112Not Yet Recruiting
Marseille, France
CHU MontpellierRecruiting
Montpellier, France
Local Institution - 0114Not Yet Recruiting
Paris, France
Local Institution - 0102Not Yet Recruiting
Paris, France
Local Institution - 0108Not Yet Recruiting
Pessac, France
CHU de Rennes - Hopital de PontchaillouRecruiting
Rennes, France
Centre Henri BecquerelRecruiting
Rouen, France
Local Institution - 0110Not Yet Recruiting
Saint-Cloud, France
Local Institution - 0115Not Yet Recruiting
Strasbourg, France
Institut Universitaire du Cancer de Toulouse (IUCT) - OncopoleRecruiting
Toulouse, France
Local Institution - 0116Not Yet Recruiting
Vandœuvre-lès-Nancy, France
Local Institution - 0202Not Yet Recruiting
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum UlmRecruiting
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum KölnRecruiting
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum EssenRecruiting
Essen, North Rhine-Westphalia, Germany
Klinikum Chemnitz gGmbHRecruiting
Chemnitz, Saxony, Germany
Charité - Universitätsmedizin BerlinRecruiting
Berlin, Germany
Local Institution - 0207Not Yet Recruiting
Göttingen, Germany
Universitätsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany
Universitätsklinikum HeidelbergRecruiting
Heidelberg, Germany
Klinikum Stuttgart - KatharinenhospitalRecruiting
Stuttgart, Germany