Lisocabtagene MaraleucelA 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

Sponsor:

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

Code:

NCT07015242

Conditions

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rituximab

Methotrexate

Procarbazine

Temozolomide

Liso-cel

Study Details

Brief summary:

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).

Conditions

Lymphoma

Study ID

NCT07015242

Start date

Nov 6, 2025

Status verified date

Aug, 2026

Completion date

Dec 10, 2028

Anticipated

Primary completion date

Jan 9, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Liso-cel Administration

Interventions

Rituximab