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NCT Number: NCT05079282

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

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

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Key information

Conditions

Relapsed or Refractory T Cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ONO-4685

Drug

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

Primary outcomes

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

    Time frame: 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.

  2. Estimate of Maximum Tolerate Dose (MTD)

    Time frame: Up to 3 weeks

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

Secondary outcomes

  1. Plasma Concentration of ONO-4685

    Time frame: Up to 48 weeks

    Plasma concentration will be assessed to evaluate Pharmacokinetics

  2. Plasma Concentration of Anti-Drug Antibody (ADA)

    Time frame: Up to 48 weeks

    ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.

  3. Antitumor Activity of ONO-4685

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

    Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Oct 15, 2021
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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