Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

Description

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma

Conditions

Relapsed or Refractory T Cell Lymphoma

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Study Overview

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Study Details

Study overview

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma

An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

Condition
Relapsed or Refractory T Cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Duarte

City of Hope, Duarte, California, United States, 91010

Orange

University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Buffalo

Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

New York

New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC), New York, New York, United States, 10032

New York

Memorial Sloan-Kettering Cancer Center, New York, New York, United States, 10065

Charlotte

Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States, 28204

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients with central nervous system (CNS) involvement
  • 2. Patients with Adult T-cell leukemia/lymphoma (ATLL)
  • 3. Prior allogeneic stem cell transplant
  • 4. Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • 5. Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
  • 6. Patients with malignancies (other than T-cell lymphoma) except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years
  • 7. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
  • 8. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
  • 9. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
  • 10. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
  • 11. Women who are pregnant or lactating

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ono Pharmaceutical Co. Ltd,

Project Leader, STUDY_DIRECTOR, Ono Pharma USA Inc

Study Record Dates

2026-06-01