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
NCT ID: NCT07015242
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
65 participants
INTERVENTIONAL
2025-11-06
2028-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Liso-cel Administration
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 307
Stanford, California, United States
Local Institution - 0305
Aurora, Colorado, United States
Local Institution - 305
Aurora, Colorado, United States
Local Institution - 308
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Local Institution - 0311
Chicago, Illinois, United States
Local Institution - 311
Chicago, Illinois, United States
Local Institution - 314
Boston, Massachusetts, United States
Local Institution - 0313
Boston, Massachusetts, United States
Local Institution - 313
Boston, Massachusetts, United States
Local Institution - 0316
St Louis, Missouri, United States
Local Institution - 316
St Louis, Missouri, United States
Local Institution - 0315
New Brunswick, New Jersey, United States
Local Institution - 315
New Brunswick, New Jersey, United States
Local Institution - 0310
Buffalo, New York, United States
Local Institution - 310
Buffalo, New York, United States
Local Institution - 301
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Local Institution - 302
Cleveland, Ohio, United States
Local Institution - 0309
Columbus, Ohio, United States
Local Institution - 309
Columbus, Ohio, United States
Local Institution - 0304
Philadelphia, Pennsylvania, United States
Local Institution - 304
Philadelphia, Pennsylvania, United States
Local Institution - 312
Nashville, Tennessee, United States
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
Local Institution - 0303
Houston, Texas, United States
Local Institution - 303
Houston, Texas, United States
Local Institution - 0306
Seattle, Washington, United States
Local Institution - 306
Seattle, Washington, United States
Local Institution - 0111
Nice, Alpes-Maritimes, France
Local Institution - 111
Nice, Alpes-Maritimes, France
Local Institution - 0104
Nantes, Loire-Atlantique, France
Local Institution - 104
Nantes, Loire-Atlantique, France
Local Institution - 0103
Pierre-Bénite, Rhône, France
Local Institution - 0106
Dijon, , France
Local Institution - 106
Dijon, , France
Local Institution - 0113
Lille, , France
Local Institution - 113
Lille, , France
Local Institution - 0112
Marseille, , France
Local Institution - 112
Marseille, , France
Local Institution - 0107
Montpellier, , France
Local Institution - 107
Montpellier, , France
Local Institution - 0114
Paris, , France
Local Institution - 114
Paris, , France
Local Institution - 0102
Paris, , France
Local Institution - 102
Paris, , France
Local Institution - 0108
Pessac, , France
Local Institution - 108
Pessac, , France
Local Institution - 103
Pierre-Bénite, , France
CHU de Rennes - Hopital de Pontchaillou
Rennes, , France
Local Institution - 101
Rennes, , France
Local Institution - 0105
Rouen, , France
Local Institution - 105
Rouen, , France
Local Institution - 0110
Saint-Cloud, , France
Local Institution - 110
Saint-Cloud, , France
Local Institution - 0115
Strasbourg, , France
Local Institution - 115
Strasbourg, , France
Local Institution - 0109
Toulouse, , France
Local Institution - 109
Toulouse, , France
Local Institution - 0116
Vandœuvre-lès-Nancy, , France
Local Institution - 116
Vandœuvre-lès-Nancy, , France
Local Institution - 0202
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Local Institution - 0205
Ulm, Baden-Wurttemberg, Germany
Local Institution - 205
Ulm, Baden-Wurttemberg, Germany
Local Institution - 0204
Cologne, North Rhine-Westphalia, Germany
Local Institution - 204
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0206
Essen, North Rhine-Westphalia, Germany
Local Institution - 206
Essen, North Rhine-Westphalia, Germany
Local Institution - 0208
Chemnitz, Saxony, Germany
Local Institution - 208
Chemnitz, Saxony, Germany
Local Institution - 0203
Berlin, , Germany
Local Institution - 203
Berlin, , Germany
Local Institution - 202
Freiburg im Breisgau, , Germany
Local Institution - 0207
Göttingen, , Germany
Local Institution - 207
Göttingen, , Germany
Local Institution - 0209
Hamburg, , Germany
Local Institution - 209
Hamburg, , Germany
Local Institution - 210
Heidelberg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Local Institution - 0201
Stuttgart, , Germany
Local Institution - 201
Stuttgart, , Germany
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Site 0305
Role: primary
Michael Jain, Site 0308
Role: primary
Site 0311
Role: primary
Site 0313
Role: primary
Site 0316
Role: primary
Site 0315
Role: primary
Site 0310
Role: primary
Michael Scordo, Site 0301
Role: primary
Allison Winter, Site 0302
Role: primary
Site 0309
Role: primary
Site 0304
Role: primary
Krish Patel, Site 0312
Role: primary
Site 0303
Role: primary
Site 0306
Role: primary
Site 0111
Role: primary
Site 0104
Role: primary
Site 0103
Role: primary
Site 0106
Role: primary
Site 106
Role: primary
Site 0113
Role: primary
Site 113
Role: primary
Site 0112
Role: primary
Site 112
Role: primary
Site 0107
Role: primary
Site 107
Role: primary
Site 0114
Role: primary
Site 114
Role: primary
Site 0102
Role: primary
Site 0108
Role: primary
Roch Houot, Site 0101
Role: primary
Site 0105
Role: primary
Site 105
Role: primary
Site 0110
Role: primary
Site 0115
Role: primary
Site 0109
Role: primary
Site 0116
Role: primary
Site 0202
Role: primary
Site 0205
Role: primary
Site 0204
Role: primary
Site 0206
Role: primary
Site 0208
Role: primary
Site 0203
Role: primary
Site 0207
Role: primary
Site 0209
Role: primary
Peter Dreger, Site 0210
Role: primary
Site 0201
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-521144-38
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1318-3732
Identifier Type: OTHER
Identifier Source: secondary_id
CA082-1215
Identifier Type: -
Identifier Source: org_study_id
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