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Trial ID CA082-1215  |   NCT07015242

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 41
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Participant must be 18 years or older at the time of signing the informed consent form (ICF).
    1. Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology.
      1. 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.
        1. Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen.
          1. 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.
            1. 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.
              1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
                1. 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

                  Exclusion Criteria Icon
                  :
                  • Participant has a diagnosis of secondary CNS lymphoma due to systemic disease.
                    1. Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL) and isolated cerebrospinal fluid (CSF) disease.
                      1. 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.
                        1. History of another primary malignancy that has not been in remission for ≥2 years.
                          1. Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology.
                            1. History of or active human immunodeficiency virus (HIV).
                              1. Active hepatitis B or active hepatitis C.
                                1. Active autoimmune disease requiring immunosuppressive therapy.
                                  Additional Information *
                                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                                    Treatment Options

                                    Study Arms

                                    ASSIGNED INTERVENTION

                                    Study Arms

                                    Experimental: Liso-cel Administration

                                    ASSIGNED INTERVENTION
                                    • Drug: Rituximab, Methotrexate, Procarbazine, Temozolomide, Fludarabine, Cyclophosphamide, Calcium folinate
                                    • Biological: Liso-cel
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