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RecruitingInterventionalPhase 1

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

NCT ID: NCT05079282Sponsor: Ono Pharmaceutical Co., Ltd.Last updated: 2026-02-13

Summary

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

Arms & interventions

  • DrugONO-4685

    ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed

Outcome measures

Primary

  • Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).

    Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.

    Time frame: Through study completion, an average of 1 year

  • Estimate of Maximum Tolerate Dose (MTD)

    MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment

    Time frame: Up to 3 weeks

Secondary

  • Plasma Concentration of ONO-4685

    Time frame: Up to 48 weeks

  • Plasma Concentration of Anti-Drug Antibody (ADA)

    Time frame: Up to 48 weeks

  • Antitumor Activity of ONO-4685

    Time frame: Through study completion, an average of 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Completed

City of Hope

Duarte, California, 91010

Recruiting

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

Orange, California, 92868

Recruiting

Stanford Cancer Institute

Palo Alto, California, 94304

Recruiting

Yale Cancer Center

New Haven, Connecticut, 06519

Recruiting

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110

Recruiting

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601

Recruiting

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting

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

New York, New York, 10032

Recruiting

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

Recruiting

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204

Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting

Oregon Health & Science University

Portland, Oregon, 97239

Recruiting

University of Pennsylvania - Perelman Center

Philadelphia, Pennsylvania, 19104

Recruiting

Vanderbilt University - Ingram Cancer Center

Nashville, Tennessee, 37232

Recruiting

UT Southwestern Medical Center

Dallas, Texas, 75390

Recruiting

MD Anderson

Houston, Texas, 77030

Recruiting