RecruitingLymphoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

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).

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

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.