Home › Trials › NCT07015242

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

The CAROLYN Trial: Lisocabtagene Maraleucelas First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

Phase 2 Interventional Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT07015242

This will test whether lisocabtagene maraleucel (liso-cel), given with a high-dose methotrexate–based regimen, is safe and works as first treatment for adults with primary CNS lymphoma who cannot have a transplant.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment65 (estimated)
Ages18 Years and up
SexAll
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored
Drugs / interventionsCAR T, methotrexate
Locations82 sites (Stanford, California and 81 other locations)
Trial IDNCT07015242 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed PCNSL who are judged transplant-ineligible (for example age ≥65 or HCT-CI ≥3), are suitable for high-dose methotrexate–based therapy, and whose disease showed a complete or partial response to prior HD‑MTX–based regimens are ideal candidates.

Not a fit: Patients who are transplant-eligible, whose disease is refractory to high-dose methotrexate, or who have medical conditions that preclude CAR T-cell therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, liso-cel could produce deeper or longer remissions and offer a transplant-sparing option for older or medically unfit adults with PCNSL.

How similar studies have performed: CAR T therapies like liso-cel are approved for other B-cell lymphomas and small early studies/case series have shown activity in CNS lymphoma, but using liso-cel as first-line therapy in transplant-ineligible PCNSL is a novel approach with limited prior data.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Stanford, California and 81 other locations

+32 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.