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

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

  • Lymphoma

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