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New hope for tough blood cancers: early trial of ONO-7018 begins

NCT ID NCT05515406

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called ONO-7018 in 9 adults with non-Hodgkin lymphoma or chronic lymphocytic leukemia that had returned or stopped responding to other treatments. The main goal was to find a safe dose and check for side effects. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Feb 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged ≥ 18 years 2. Written informed consent by the patient or the patient's legally authorized representative 3. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL 4. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit 5. Patient who has measurable disease 6. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy 7. Eastern Cooperative Oncology Group Performance Status 0 to 2 8. Adequate bone marrow, renal and hepatic functions Exclusion Criteria: 1. History of lymphoid malignancy other than those allowed per inclusion criteria 2. Patient with central nervous system involvement 3. Patient with systemic and active infection 4. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results 5. Prior treatment with a MALT1 inhibitor 6. Patient receiving any other investigational drug within 4 weeks prior to study entry 7. Patient is unable to swallow tablets 8. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia leukemia lymphoma lymphoma, non-Hodgkin, familial non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, lymphocytic, chronic, B-cell Lymphoma, non-Hodgkin

Contacts and locations

Locations

  • AMR Kansas City

    Kansas City, Missouri, 64114, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246, United States

  • Jonsson Comprehensive Cancer Center

    Santa Monica, California, 90404, United States

  • Leo Jenkins Cancer Center/ECU School of Medicine

    Greenville, North Carolina, 27858, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Northwest Medical Specialities

    Tacoma, Washington, 98405, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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