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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
Trial Status: active
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).
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT07015242.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not Available
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationJuno Therapeutics, Inc., a Bristol-Myers Squibb Company