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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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
~65 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:RituximabMethotrexateProcarbazineTemozolomideLiso-celFludarabine

At a glance

Recruiting sites
29 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS)
Measured over 12 months after liso-cel infusion

Conditions

Lymphoma

Explore related trials

Primary Central Nervous System Lymphoma

NCT07015242

Where you'd take part

This study runs at 40 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, Loire-Atlantique, Francestudy coordinator listed

    Recruiting

  • Chru De Lille - Hopital Claude Huriez

    Lille, Francestudy coordinator listed

    Recruiting

  • CHU de Dijon Bourgogne - Hopital Francois Mitterand

    Dijon, Francestudy coordinator listed

    Recruiting

  • CHU de Rennes - Hopital de Pontchaillou

    Rennes, Francestudy coordinator listed

    Recruiting

  • CHU Montpellier

    Montpellier, Francestudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

    Toulouse, Francestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 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.
No prior experimental treatments for PCNSL.
Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.

Exclusion

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.
History of prior allogeneic transplant, or solid organ transplant requiring immunosuppressive therapy.

What this trial measures

  • Progression-free Survival (PFS)12 months after liso-cel infusion

    Defined as the time from the date of liso-cel infusion to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first