RecruitingPhase 1NCT05079282

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

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

Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

217 participants

Start Date

Dec 10, 2021

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory T Cell Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing ONO-4685, a new drug designed to boost the immune system's ability to fight T-cell lymphoma (a cancer of a type of white blood cell), in patients whose lymphoma has come back or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL, stages IIB–IV) - You have received at least 2 prior treatments - You have measurable or assessable disease - Your general health is adequate (ECOG 0–2) and life expectancy is at least 3 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have T-cell lymphoma involving the brain - You have adult T-cell leukemia/lymphoma (ATLL) - You have had a prior stem cell transplant or CAR-T cell therapy - You have received prior treatment with checkpoint inhibitors (PD-1, PD-L1, CTLA-4) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(20)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

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

Orange, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

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

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania - Perelman Center

Philadelphia, Pennsylvania, United States

Vanderbilt University - Ingram Cancer Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

MD Anderson

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05079282