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

Recruiting now · Phase 1

Conditions studied: Relapsed or Refractory T Cell Lymphoma

In brief

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

Key facts

Study ID

NCT05079282

Run by

Ono Pharmaceutical Co., Ltd.

People needed

217

Starts

2021-12-10

Expected to finish

2028-08-31

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients with central nervous system (CNS) involvement
• Patients with Adult T-cell leukemia/lymphoma (ATLL)
• Prior allogeneic stem cell transplant
• 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
• Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
• 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
• History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
• History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
• Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
• Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
• Women who are pregnant or lactating

Where it is running

• MD Anderson — Houston, Texas, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
• Stanford Cancer Institute — Palo Alto, California, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (enrolling)
• Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) — New York, New York, United States (enrolling)
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States (enrolling)
• Novant Health Presbyterian Medical Center — Charlotte, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania - Perelman Center — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt University - Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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