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Active, not recruiting Phase 1

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

NCT05079282 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2021-12-10
Last updated
2026-09-29

Condition(s) studied

Relapsed or Refractory T Cell Lymphoma

Investigational drug(s) / intervention(s)

ONO-4685 →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy 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

Primary outcome measure(s)

  • Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs). — Through study completion, an average of 1 year
    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.
  • Estimate of Maximum Tolerate Dose (MTD) — Up to 3 weeks
    MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment

Trial sites (21)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05079282 on ClinicalTrials.gov ↗ ← All trials in the USA