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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

NCT07015242 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Official title
The CAROLYN Trial: Lisocabtagene Maraleucelas 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 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 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: 2026-03-24
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 (82)
Local Institution - 307Withdrawn
Stanford, California, United States
Local Institution - 0305Not Yet Recruiting
Aurora, Colorado, United States
Local Institution - 305Withdrawn
Aurora, Colorado, United States
Local Institution - 308Withdrawn
Tampa, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Local Institution - 0311Not Yet Recruiting
Chicago, Illinois, United States
Local Institution - 311Withdrawn
Chicago, Illinois, United States
Local Institution - 314Withdrawn
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Local Institution - 313Withdrawn
Boston, Massachusetts, United States
Local Institution - 316Withdrawn
St Louis, Missouri, United States
Washington University School of Medicine in St. LouisRecruiting
St Louis, Missouri, United States
Local Institution - 0315Not Yet Recruiting
New Brunswick, New Jersey, United States
Local Institution - 315Withdrawn
New Brunswick, New Jersey, United States
Local Institution - 310Withdrawn
Buffalo, New York, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
Local Institution - 301Withdrawn
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Local Institution - 302Withdrawn
Cleveland, Ohio, United States
Local Institution - 309Withdrawn
Columbus, Ohio, United States
The Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
Local Institution - 304Withdrawn
Philadelphia, Pennsylvania, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Local Institution - 312Withdrawn
Nashville, Tennessee, United States
Sarah Cannon Research Institute Oncology PartnersRecruiting
Nashville, Tennessee, United States
Local Institution - 0303Not Yet Recruiting
Houston, Texas, United States
Local Institution - 303Withdrawn
Houston, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Local Institution - 306Withdrawn
Seattle, Washington, United States
Local Institution - 0111Not Yet Recruiting
Nice, Alpes-Maritimes, France
Local Institution - 111Withdrawn
Nice, Alpes-Maritimes, France
Local Institution - 0104Not Yet Recruiting
Nantes, Loire-Atlantique, France
Local Institution - 104Withdrawn
Nantes, Loire-Atlantique, France
Local Institution - 0103Not Yet Recruiting
Pierre-Bénite, Rhône, France
Local Institution - 0106Not Yet Recruiting
Dijon, France
Local Institution - 106Not Yet Recruiting
Dijon, France
Local Institution - 0113Not Yet Recruiting
Lille, France
Local Institution - 113Not Yet Recruiting
Lille, France
Local Institution - 0112Not Yet Recruiting
Marseille, France
Local Institution - 112Not Yet Recruiting
Marseille, France
Local Institution - 0107Not Yet Recruiting
Montpellier, France
Local Institution - 107Not Yet Recruiting
Montpellier, France
Local Institution - 0114Not Yet Recruiting
Paris, France
Local Institution - 114Not Yet Recruiting
Paris, France
Local Institution - 0102Not Yet Recruiting
Paris, France
Local Institution - 102Withdrawn
Paris, France
Local Institution - 0108Not Yet Recruiting
Pessac, France
Local Institution - 108Withdrawn
Pessac, France
Local Institution - 103Withdrawn
Pierre-Bénite, France
CHU de Rennes - Hopital de PontchaillouRecruiting
Rennes, France
Local Institution - 101Withdrawn
Rennes, France
Local Institution - 0105Not Yet Recruiting
Rouen, France
Local Institution - 105Not Yet Recruiting
Rouen, France
Local Institution - 0110Not Yet Recruiting
Saint-Cloud, France
Local Institution - 110Withdrawn
Saint-Cloud, France
Local Institution - 0115Not Yet Recruiting
Strasbourg, France
Local Institution - 115Withdrawn
Strasbourg, France
Local Institution - 0109Not Yet Recruiting
Toulouse, France
Local Institution - 109Withdrawn
Toulouse, France
Local Institution - 0116Not Yet Recruiting
Vandœuvre-lès-Nancy, France
Local Institution - 116Withdrawn
Vandœuvre-lès-Nancy, France
Local Institution - 0202Not Yet Recruiting
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Local Institution - 205Withdrawn
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum UlmRecruiting
Ulm, Baden-Wurttemberg, Germany
Local Institution - 0204Not Yet Recruiting
Cologne, North Rhine-Westphalia, Germany
Local Institution - 204Withdrawn
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0206Not Yet Recruiting
Essen, North Rhine-Westphalia, Germany
Local Institution - 206Withdrawn
Essen, North Rhine-Westphalia, Germany
Klinikum Chemnitz gGmbHRecruiting
Chemnitz, Saxony, Germany
Local Institution - 208Withdrawn
Chemnitz, Saxony, Germany
Charité - Universitätsmedizin BerlinRecruiting
Berlin, Germany
Local Institution - 203Withdrawn
Berlin, Germany
Local Institution - 202Withdrawn
Freiburg im Breisgau, Germany
Local Institution - 0207Not Yet Recruiting
Göttingen, Germany
Local Institution - 207Withdrawn
Göttingen, Germany
Local Institution - 209Withdrawn
Hamburg, Germany
Universitätsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany
Local Institution - 210Withdrawn
Heidelberg, Germany
Universitätsklinikum HeidelbergRecruiting
Heidelberg, Germany
Klinikum Stuttgart - KatharinenhospitalRecruiting
Stuttgart, Germany
Local Institution - 201Withdrawn
Stuttgart, Germany
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 · TrialPath