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NCT05079282PHASE1Recruiting

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

Ono Pharmaceutical Co., Ltd.

Start Date

12/10/2021

Completion Date

8/31/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria 1. Patients aged ≥ 18 years at time of screening 2. Written informed consent by the patient or the patients' legally authorized representative prior to screening 3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma: 1. Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL) 2. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS) 4. Patients must have received at least 2 prior systemic therapies 5. Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014) 6. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011) 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2 8. Life expectancy of at least 3 months 9. Adequate bone marrow, renal and hepatic functions Exclusion 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

Interventions

DRUG

ONO-4685

Interested in This Trial?

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Conditions

Relapsed or Refractory T Cell Lymphoma

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

City of Hope

Duarte, California 91010

United States

University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

Stanford Cancer Institute

Palo Alto, California 94304

United States

Yale Cancer Center

New Haven, Connecticut 06519

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Washington University School of Medicine in St. Louis

St Louis, Missouri 63110

United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey 07601

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

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

New York, New York 10032

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina 28204

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

University of Pennsylvania - Perelman Center

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University - Ingram Cancer Center

Nashville, Tennessee 37232

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

MD Anderson

Houston, Texas 77030

United States