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Clinical Trials in the USA / NCT07015242
Recruiting Phase 2

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

NCT07015242 · tracked via the Priya Life Science USA tracker
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Phase
Phase 2
Started
2025-11-06
Last updated
2026-09-01

Condition(s) studied

Lymphoma

Investigational drug(s) / intervention(s)

RituximabMethotrexateProcarbazineTemozolomideLiso-celFludarabineCyclophosphamideCalcium folinate

Rituximab: Specified dose on specified days

Methotrexate: Specified dose on specified days

Procarbazine: Specified dose on specified days

Temozolomide: Specified dose on specified days

Liso-cel: Specified dose on specified days

Fludarabine: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Calcium folinate: Specified dose on specified days

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
University Of Colorado Aurora Colorado Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Washington University School of Medicine in St. Louis St Louis Missouri Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
The Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Sarah Cannon Research Institute Oncology Partners Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Local Institution - 0111 Nice Alpes-Maritimes Not Yet Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Loire-Atlantique Recruiting
Local Institution - 0103 Pierre-Bénite Rhône Not Yet Recruiting
CHU de Dijon Bourgogne - Hopital Francois Mitterand Dijon France Recruiting
Chru De Lille - Hopital Claude Huriez Lille France Recruiting
Local Institution - 0112 Marseille France Not Yet Recruiting
CHU Montpellier Montpellier France Recruiting
Local Institution - 0114 Paris France Not Yet Recruiting
Local Institution - 0102 Paris France Not Yet Recruiting
Local Institution - 0108 Pessac France Not Yet Recruiting
CHU de Rennes - Hopital de Pontchaillou Rennes France Recruiting
Centre Henri Becquerel Rouen France Recruiting
Local Institution - 0110 Saint-Cloud France Not Yet Recruiting
Local Institution - 0115 Strasbourg France Not Yet Recruiting
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole Toulouse France Recruiting
Local Institution - 0116 Vandœuvre-lès-Nancy France Not Yet Recruiting
Local Institution - 0202 Freiburg im Breisgau Baden-Wurttemberg Not Yet Recruiting
Universitätsklinikum Ulm Ulm Baden-Wurttemberg Recruiting
Universitätsklinikum Köln Cologne North Rhine-Westphalia Recruiting
Universitätsklinikum Essen Essen North Rhine-Westphalia Recruiting
Klinikum Chemnitz gGmbH Chemnitz Saxony Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Local Institution - 0207 Göttingen Germany Not Yet Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Recruiting
Universitätsklinikum Heidelberg Heidelberg Germany Recruiting
Klinikum Stuttgart - Katharinenhospital Stuttgart Germany Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07015242 on ClinicalTrials.gov ↗ ← All trials in the USA