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

NCT05079282 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ONO-4685-03
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Relapsed or Refractory T Cell Lymphoma

Keywords

ONO-4685; PD-1; CD3; Bispecific antibody; PTCL; AITL; PTCL-NOS; nodal PTCL with TFH; FTCL; CTCL; MF; SS

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Up to 3 weeks

Secondary Outcomes (3)

• Plasma Concentration of ONO-4685

  Up to 48 weeks

• Plasma Concentration of Anti-Drug Antibody (ADA)

  Up to 48 weeks

• Antitumor Activity of ONO-4685

  Through study completion, an average of 1 year

Study Arms (1)

ONO-4685 monotherapy

EXPERIMENTAL

Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

Drug: ONO-4685

Interventions

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

ONO-4685 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

COMPLETED

City of Hope

Duarte, California, 91010, United States

RECRUITING

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

Orange, California, 92868, United States

RECRUITING

Stanford Cancer Institute

Palo Alto, California, 94304, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06519, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

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

New York, New York, 10032, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania - Perelman Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University - Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free); clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard); clinical_trial@ono-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 15, 2021
• Study Start: December 10, 2021
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)