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

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Sponsor score: 0

ClinicalTrials ID:NCT07015242

This clinical trial assesses the safety and efficacy of liso-cel in adults with PCNSL who are ineligible for transplant. Participants will receive a combination of interventions, including rituximab, methotrexate, procarbazine, temozolomide, fludarabine, cyclophosphamide, and calcium folinate, administered in specified doses on designated days. Eligibility criteria focus on adults with confirmed PCNSL.

Patient Parameters

Program 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).

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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 30794305StanfordCalifornia
Local Institution - 030580045AuroraColorado
Local Institution - 30580045AuroraColorado
Local Institution - 30833612-9416TampaFlorida
Moffitt Cancer Center33612-9416TampaFlorida
Local Institution - 031160611ChicagoIllinois
Local Institution - 31160611ChicagoIllinois
Local Institution - 31402214BostonMassachusetts
Local Institution - 031302215BostonMassachusetts
Local Institution - 31302215BostonMassachusetts

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