Lisocabtagene maraleucel (liso-cel) as first-line treatment for adults with transplant-ineligible primary central nervous system lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial testing liso-cel (a CAR T-cell therapy) in adults with transplant-ineligible primary central nervous system lymphoma (PCNSL). Eligible participants must have histologically confirmed PCNSL and disease that responded (CR or PR) to prior high-dose methotrexate–based regimens, and must be judged transplant-ineligible (for example age ≥65 or HCT-CI ≥3). Participants receive methotrexate-based chemotherapy and associated agents (rituximab, procarbazine, temozolomide as per protocol) with collection of cells for liso-cel manufacture and subsequent CAR T infusion. The trial will monitor safety (including neurotoxicity and cytokine release syndrome) and signals of efficacy such as response rate and duration of remission.

Why it matters

Who can join: the full rules

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 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 Criteria

* 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.

  a. Exceptions include certain adequately treated non-invasive malignancies, localized prostate cancer treated with curative intent, and completely resected Stage 1 solid tumors with a low risk of recurrence.
* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• University Of Colorado
  Aurora, Colorado, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  Chicago, Illinois, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Washington University School of Medicine in St. Louis
  St Louis, Missouri, United States Recruiting
• Rutgers Cancer Institute of New Jersey
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.