Clinical Trial 23735

• Overview

  Study Title:

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

  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).

  Objective:

  Primary: -To evaluate whether liso-cel infusion results in improved efficacy, with respect to a theoretical value derived from historical references, in first line therapy for PCNSL in transplant-ineligible patients, based on investigator-assessed 12-month progression-free survival (PFS) probability. Secondary: -To assess additional parameters of efficacy of liso-cel in first line PCNSL -To assess health-related quality of life (HRQoL) measures in first line PCNSL receiving liso-cel

• Treatments

  Therapies:

  Cell Therapy

  Medications:

  lisocabtagene maraleucel ()

• Inclusion Criteria

  Key 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

  Key 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.

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