RecruitingPhase 1NCT06547528

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)


Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

108 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study for a new drug called ONO-4685, used alone, in people with certain types of T-cell lymphoma or a blood cancer called CLL/SLL. T-cell lymphomas are cancers of a specific type of immune cell. The study is mainly focused on finding a safe dose and understanding how the drug behaves in the body. **You may be eligible if...** - You have been diagnosed with one of the following: peripheral T-cell lymphoma (PTCL), angioimmunoblastic T-cell lymphoma (AITL), cutaneous T-cell lymphoma (such as mycosis fungoides or Sézary syndrome), or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) - Your cancer has come back or stopped responding to prior treatments, and no better standard treatment options are available - You are in reasonably good physical health and your organs are functioning adequately - You are 18 years of age or older **You may NOT be eligible if...** - You have had certain serious infections like active hepatitis B/C or HIV - You have had a stem cell transplant recently or have graft-versus-host disease - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active brain involvement from your cancer 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(14)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Akita University Hospital

Akita, Akita, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Tokai University Hospital

Isehara-shi, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Kindai University Hospital

Osaka Sayama-shi, Osaka, Japan

Osaka University Hospital

Osaka-fu, Osaka, Japan

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06547528