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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 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.

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. - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Liso-cel Administration
  • Drug: Rituximab
    Specified dose on specified days
  • Drug: Methotrexate
    Specified dose on specified days
  • Drug: Procarbazine
    Specified dose on specified days
  • Drug: Temozolomide
    Specified dose on specified days
  • Biological: Liso-cel
    Specified dose on specified days
    Other names:
    • JCAR017
    • Breyanzi
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days
  • Drug: Calcium folinate
    Specified dose on specified days
    Other names:
    • Leucovorin

Recruiting Locations

University Of Colorado
Aurora, Colorado 80045
Contact:
Bradley Haverkos, Site 0305
513-543-8460

Moffitt Cancer Center
Tampa, Florida 33612-9416
Contact:
Supreet Kaur, Site 0308

Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611
Contact:
Reem Karmali, Site 0311
312-695-0990

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Lakshmi Nayak, Site 0313
617-632-2166

Washington University School of Medicine in St. Louis
St Louis, Missouri 63110-1010
Contact:
Armin Ghobadi, Site 0316
314-454-8323

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
Contact:
Matt Matasar, Site 0315
405-713-4950

Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
Contact:
Grant Schofield, Site 0310

Memorial Sloan Kettering Cancer Center
New York, New York 10021
Contact:
Michael Scordo, Site 0301
646-608-4132

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Allison Winter, Site 0302
216-445-4782

The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43202-2224
Contact:
Nathan Denlinger, Site 0309

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Sunita Nasta, Site 0304
215-662-6933

Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee 37203
Contact:
Krish Patel, Site 0312
206-215-2338

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Ayushi Chauhan, Site 0303

Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Vyshak Alva Venur, Site 0306

More Details

Status
Recruiting
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.