Actively Recruiting
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
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-03-24
65
Participants Needed
82
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 63.
- 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.
You will not qualify if you...
- 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 62 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 82 locations
1
Local Institution - 307
Stanford, California, United States, 94305
Withdrawn
2
Local Institution - 0305
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
Local Institution - 305
Aurora, Colorado, United States, 80045
Withdrawn
4
Local Institution - 308
Tampa, Florida, United States, 33612-9416
Withdrawn
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612-9416
Actively Recruiting
6
Local Institution - 0311
Chicago, Illinois, United States, 60611
Not Yet Recruiting
7
Local Institution - 311
Chicago, Illinois, United States, 60611
Withdrawn
8
Local Institution - 314
Boston, Massachusetts, United States, 02214
Withdrawn
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Local Institution - 313
Boston, Massachusetts, United States, 02215
Withdrawn
11
Local Institution - 316
St Louis, Missouri, United States, 63110-1010
Withdrawn
12
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
13
Local Institution - 0315
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
14
Local Institution - 315
New Brunswick, New Jersey, United States, 08901
Withdrawn
15
Local Institution - 310
Buffalo, New York, United States, 14263
Withdrawn
16
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
17
Local Institution - 301
New York, New York, United States, 10021
Withdrawn
18
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
19
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
Local Institution - 302
Cleveland, Ohio, United States, 44195
Withdrawn
21
Local Institution - 309
Columbus, Ohio, United States, 43202-2224
Withdrawn
22
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43202-2224
Actively Recruiting
23
Local Institution - 304
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
24
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Local Institution - 312
Nashville, Tennessee, United States, 37203
Withdrawn
26
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
27
Local Institution - 0303
Houston, Texas, United States, 77030
Not Yet Recruiting
28
Local Institution - 303
Houston, Texas, United States, 77030
Withdrawn
29
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
30
Local Institution - 306
Seattle, Washington, United States, 98109
Withdrawn
31
Local Institution - 0111
Nice, Alpes-Maritimes, France, 06202
Not Yet Recruiting
32
Local Institution - 111
Nice, Alpes-Maritimes, France, 06202
Withdrawn
33
Local Institution - 0104
Nantes, Loire-Atlantique, France, 44093 Cedex 1
Not Yet Recruiting
34
Local Institution - 104
Nantes, Loire-Atlantique, France, 44093 Cedex 1
Withdrawn
35
Local Institution - 0103
Pierre-Bénite, Rhône, France, 69495
Not Yet Recruiting
36
Local Institution - 0106
Dijon, France, 21079
Not Yet Recruiting
37
Local Institution - 106
Dijon, France, 21079
Not Yet Recruiting
38
Local Institution - 0113
Lille, France, 59037
Not Yet Recruiting
39
Local Institution - 113
Lille, France, 59037
Not Yet Recruiting
40
Local Institution - 0112
Marseille, France, 13273
Not Yet Recruiting
41
Local Institution - 112
Marseille, France, 13273
Not Yet Recruiting
42
Local Institution - 0107
Montpellier, France, 34295
Not Yet Recruiting
43
Local Institution - 107
Montpellier, France, 34295
Not Yet Recruiting
44
Local Institution - 0114
Paris, France, 75010
Not Yet Recruiting
45
Local Institution - 114
Paris, France, 75010
Not Yet Recruiting
46
Local Institution - 0102
Paris, France, 75013
Not Yet Recruiting
47
Local Institution - 102
Paris, France, 75013
Withdrawn
48
Local Institution - 0108
Pessac, France, 33600
Not Yet Recruiting
49
Local Institution - 108
Pessac, France, 33600
Withdrawn
50
Local Institution - 103
Pierre-Bénite, France, 69310
Withdrawn
51
CHU de Rennes - Hopital de Pontchaillou
Rennes, France, 35033
Actively Recruiting
52
Local Institution - 101
Rennes, France, 35033
Withdrawn
53
Local Institution - 0105
Rouen, France, 79038
Not Yet Recruiting
54
Local Institution - 105
Rouen, France, 79038
Not Yet Recruiting
55
Local Institution - 0110
Saint-Cloud, France, 92210
Not Yet Recruiting
56
Local Institution - 110
Saint-Cloud, France, 92210
Withdrawn
57
Local Institution - 0115
Strasbourg, France, 67098
Not Yet Recruiting
58
Local Institution - 115
Strasbourg, France, 67098
Withdrawn
59
Local Institution - 0109
Toulouse, France, 31059
Not Yet Recruiting
60
Local Institution - 109
Toulouse, France, 31059
Withdrawn
61
Local Institution - 0116
Vandœuvre-lès-Nancy, France, 54500
Not Yet Recruiting
62
Local Institution - 116
Vandœuvre-lès-Nancy, France, 54500
Withdrawn
63
Local Institution - 0202
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Not Yet Recruiting
64
Local Institution - 205
Ulm, Baden-Wurttemberg, Germany, 89070
Withdrawn
65
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89070
Actively Recruiting
66
Local Institution - 0204
Cologne, North Rhine-Westphalia, Germany, 50937
Not Yet Recruiting
67
Local Institution - 204
Cologne, North Rhine-Westphalia, Germany, 50937
Withdrawn
68
Local Institution - 0206
Essen, North Rhine-Westphalia, Germany, 45147
Not Yet Recruiting
69
Local Institution - 206
Essen, North Rhine-Westphalia, Germany, 45147
Withdrawn
70
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 09116
Actively Recruiting
71
Local Institution - 208
Chemnitz, Saxony, Germany, 09116
Withdrawn
72
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Actively Recruiting
73
Local Institution - 203
Berlin, Germany, 12203
Withdrawn
74
Local Institution - 202
Freiburg im Breisgau, Germany, 79106
Withdrawn
75
Local Institution - 0207
Göttingen, Germany, 37075
Not Yet Recruiting
76
Local Institution - 207
Göttingen, Germany, 37075
Withdrawn
77
Local Institution - 209
Hamburg, Germany, 20246
Withdrawn
78
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
79
Local Institution - 210
Heidelberg, Germany, 69120
Withdrawn
80
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
81
Klinikum Stuttgart - Katharinenhospital
Stuttgart, Germany, 70174
Actively Recruiting
82
Local Institution - 201
Stuttgart, Germany, 70174
Withdrawn
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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