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 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: CA082-12152025-521144-38U1111-1318-3732
• Study Type: interventional
• Target: 65
• Locations: 3 countries
• Sites: 40

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

Keywords

primary CNS lymphoma; newly diagnosed; JCAR017

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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

  12 months after liso-cel infusion

Secondary Outcomes (15)

• PFS

  12 months after date of enrollment

• Modified Progression-free Survival (mPFS)

  12 months after date of enrollment

• Complete Response Rate (CRR)

  Up to end of study (approximately 2 years)

• Overall Response Rate (ORR)

  Up to end of study (approximately 2 years)

• Duration of Response (DoR)

  12 months after liso-cel infusion

Study Arms (1)

Liso-cel Administration

EXPERIMENTAL

Drug: Rituximab; Drug: Methotrexate; Drug: Procarbazine; Drug: Temozolomide; Biological: Liso-cel; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Calcium folinate

Interventions

Rituximab DRUG

Specified dose on specified days

Liso-cel Administration

Liso-cel BIOLOGICAL

Specified dose on specified days

Also known as: JCAR017, Breyanzi

Liso-cel Administration

Fludarabine DRUG

Specified dose on specified days

Liso-cel Administration

Procarbazine DRUG

Specified dose on specified days

Liso-cel Administration

Temozolomide DRUG

Specified dose on specified days

Liso-cel Administration

Cyclophosphamide DRUG

Specified dose on specified days

Liso-cel Administration

Calcium folinate DRUG

Specified dose on specified days

Also known as: Leucovorin

Liso-cel Administration

Methotrexate DRUG

Specified dose on specified days

Liso-cel Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ICF 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.
• Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (40)

University Of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612-9416, United States

RECRUITING

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110-1010, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202-2224, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Local Institution - 0111

Nice, Alpes-Maritimes, 06202, France

NOT YET RECRUITING

Local Institution - 0104

Nantes, Loire-Atlantique, 44093 Cedex 1, France

NOT YET RECRUITING

Local Institution - 0103

Pierre-Bénite, Rhône, 69495, France

NOT YET RECRUITING

Local Institution - 0106

Dijon, 21079, France

NOT YET RECRUITING

Local Institution - 0113

Lille, 59037, France

NOT YET RECRUITING

Local Institution - 0112

Marseille, 13273, France

NOT YET RECRUITING

CHU Montpellier

Montpellier, 34295, France

RECRUITING

Local Institution - 0114

Paris, 75010, France

NOT YET RECRUITING

Local Institution - 0102

Paris, 75013, France

NOT YET RECRUITING

Local Institution - 0108

Pessac, 33600, France

NOT YET RECRUITING

CHU de Rennes - Hopital de Pontchaillou

Rennes, 35033, France

RECRUITING

Centre Henri Becquerel

Rouen, 79038, France

RECRUITING

Local Institution - 0110

Saint-Cloud, 92210, France

NOT YET RECRUITING

Local Institution - 0115

Strasbourg, 67098, France

NOT YET RECRUITING

Local Institution - 0109

Toulouse, 31059, France

NOT YET RECRUITING

Local Institution - 0116

Vandœuvre-lès-Nancy, 54500, France

NOT YET RECRUITING

Local Institution - 0202

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

NOT YET RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89070, Germany

RECRUITING

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

RECRUITING

Local Institution - 0207

Göttingen, 37075, Germany

NOT YET RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Klinikum Stuttgart - Katharinenhospital

Stuttgart, 70174, Germany

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab; Methotrexate; Procarbazine; Temozolomide; fludarabine; Cyclophosphamide; Leucovorin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): January 9, 2028
• Study Completion (Estimated): December 10, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (10); FR (16); US (14)