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RecruitingInterventionalPhase 2

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

NCT ID: NCT07015242Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLast updated: 2026-06-10

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).

Arms & interventions

  • DrugRituximab

    Specified dose on specified days

  • DrugMethotrexate

    Specified dose on specified days

  • DrugProcarbazine

    Specified dose on specified days

  • DrugTemozolomide

    Specified dose on specified days

  • BiologicalLiso-cel

    Specified dose on specified days

  • DrugFludarabine

    Specified dose on specified days

  • DrugCyclophosphamide

    Specified dose on specified days

  • DrugCalcium folinate

    Specified dose on specified days

Outcome measures

Primary

  • Progression-free Survival (PFS)

    Defined as the time from the date of liso-cel infusion to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first

    Time frame: 12 months after liso-cel infusion

Secondary

  • PFS

    Time frame: 12 months after date of enrollment

  • Modified Progression-free Survival (mPFS)

    Time frame: 12 months after date of enrollment

  • Complete Response Rate (CRR)

    Time frame: Up to end of study (approximately 2 years)

  • Overall Response Rate (ORR)

    Time frame: Up to end of study (approximately 2 years)

  • Duration of Response (DoR)

    Time frame: 12 months after liso-cel infusion

  • Event-free Survival (EFS)

    Time frame: 12 months after date of enrollment

  • Overall Survival (OS)

    Time frame: 12 months after date of enrollment

  • Number of participants with adverse events (AEs)

    Time frame: Up to end of study (approximately 2 years)

  • Number of participants with serious adverse events (SAEs)

    Time frame: Up to end of study (approximately 2 years)

  • Number of participants with adverse events of special interest (AESIs)

    Time frame: Up to end of study (approximately 2 years)

  • Number of participants with laboratory abnormalities

    Time frame: Up to end of study (approximately 2 years)

  • Health-related quality of life (HRQoL)

    Time frame: Up to end of study (approximately 2 years)

  • Health-related quality of life (HRQoL)

    Time frame: Up to end of study (approximately 2 years)

  • Neurocognitive performance (Trial Making Test - Parts A and B)

    Time frame: Up to end of study (approximately 2 years)

  • Neurocognitive performance (Montreal Cognitive Assessment (MoCA))

    Time frame: Up to end of study (approximately 2 years)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 ICF 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. * 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. * 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 locations (14)

University Of Colorado

Aurora, Colorado, 80045

Recruiting
Bradley Haverkos, Site 0305 · Contact

Moffitt Cancer Center

Tampa, Florida, 33612-9416

Recruiting
Supreet Kaur, Site 0308 · Contact

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611

Recruiting
Reem Karmali, Site 0311 · Contact

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Lakshmi Nayak, Site 0313 · Contact

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110-1010

Recruiting
Armin Ghobadi, Site 0316 · Contact

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Recruiting
Matt Matasar, Site 0315 · Contact

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

Recruiting
Grant Schofield, Site 0310 · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Recruiting
Michael Scordo, Site 0301 · Contact

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Allison Winter, Site 0302 · Contact

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202-2224

Recruiting
Nathan Denlinger, Site 0309 · Contact

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Sunita Nasta, Site 0304 · Contact

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203

Recruiting
Krish Patel, Site 0312 · Contact

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Ayushi Chauhan, Site 0303 · Contact

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Vyshak Alva Venur, Site 0306 · Contact