Clinical trial NCT07015242: 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
Official title: The CAROLYN Trial: Lisocabtagene Maraleucelas First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 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:

* 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 ≥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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 12 months after liso-cel infusion
Secondary outcomes:
measure: PFS
timeFrame: 12 months after date of enrollment
measure: Modified Progression-free Survival (mPFS)
timeFrame: 12 months after date of enrollment
measure: Complete Response Rate (CRR)
timeFrame: Up to end of study (approximately 2 years)
measure: Overall Response Rate (ORR)
timeFrame: Up to end of study (approximately 2 years)
measure: Duration of Response (DoR)
timeFrame: 12 months after liso-cel infusion
measure: Event-free Survival (EFS)
timeFrame: 12 months after date of enrollment
measure: Overall Survival (OS)
timeFrame: 12 months after date of enrollment
measure: Health-related quality of life (HRQoL)
timeFrame: Up to end of study (approximately 2 years)
measure: Health-related quality of life (HRQoL)
timeFrame: Up to end of study (approximately 2 years)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Local Institution - 307
state: California
city: Aurora
country: United States
facility: Local Institution - 305
state: Colorado
city: Tampa
country: United States
facility: Local Institution - 308
state: Florida
city: Chicago
country: United States
facility: Local Institution - 311
state: Illinois
city: Boston
country: United States
facility: Local Institution - 314
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 313
state: Massachusetts
city: New Brunswick
country: United States
facility: Local Institution - 315
state: New Jersey
city: Buffalo
country: United States
facility: Local Institution - 310
state: New York
city: New York
country: United States
facility: Local Institution - 301
state: New York
city: Cleveland
country: United States
facility: Local Institution - 302
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 309
state: Ohio
city: Philadelphia
country: United States
facility: Local Institution - 304
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 312
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 303
state: Texas
city: Seattle
country: United States
facility: Local Institution - 306
state: Washington
city: Nice
country: France
facility: Local Institution - 111
state: Alpes-Maritimes
city: Nantes
country: France
facility: Local Institution - 104
state: Loire-Atlantique
city: Dijon Cedex
country: France
facility: Local Institution - 106
city: Lille
country: France
facility: Local Institution - 113
city: Marseille cedex
country: France
facility: Local Institution - 112
city: Montpellier
country: France
facility: Local Institution - 107
city: Paris
country: France
facility: Local Institution - 114
city: Paris
country: France
facility: Local Institution - 102
city: Pessac
country: France
facility: Local Institution - 108
city: Pierre Bénite
country: France
facility: Local Institution - 103
city: Rennes Cedex 09
country: France
facility: Local Institution - 101
city: Rouen Cedex
country: France
facility: Local Institution - 105
city: Saint-Cloud
country: France
facility: Local Institution - 110
city: Strasbourg
country: France
facility: Local Institution - 115
city: Toulouse Cedex 9
country: France
facility: Local Institution - 109
city: Vandoeuvre les Nancy
country: France
facility: Local Institution - 116
city: Ulm
country: Germany
facility: Local Institution - 205
state: Baden-Württemberg
city: Essen
country: Germany
facility: Local Institution - 206
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Local Institution - 204
state: Nordrhein-Westfalen
city: Chemnitz
country: Germany
facility: Local Institution - 208
state: SN
city: Berlin
country: Germany
facility: Local Institution - 203
city: Freiburg
country: Germany
facility: Local Institution - 202
city: Gottingen
country: Germany
facility: Local Institution - 207
city: Hamburg
country: Germany
facility: Local Institution - 209
city: Heidelberg
country: Germany
facility: Local Institution - 210
city: Stuttgart
country: Germany
facility: Local Institution - 201
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: