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New hope for tough leukemias: experimental drug LBS-007 enters human testing

NCT ID NCT05756322

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 study tests an experimental drug called LBS-007 in adults with acute leukemias (AML or ALL) that have returned or not responded to standard treatments. The main goals are to find a safe dose and see if the drug can control the disease. About 90 participants will receive the drug in increasing doses to check for side effects and signs of effectiveness.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 120 years

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: * Male or female subjects greater than 18 years old, inclusive. * Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL. * Patients who are ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. Exclusion Criteria: * Concomitant chemotherapy, radiation therapy, or immunotherapy. * Receiving any other investigational agents concurrently or within 30 days prior to screening. * Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement. * History of another active malignancy with 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively. * Patient with mental deficits and/or psychiatric history that precludes them from giving informed consent or from following protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China Medical University Hospital

    NOT_YET_RECRUITING

    Taichung, Taiwan

  • Hollywood Private Hospital

    WITHDRAWN

    Nedlands, Washington, Australia

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, 300020, China

  • Jining No.1 People's Hospital

    RECRUITING

    Jining, Shandong, 272011, China

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Cheng Kung University Hospital

    NOT_YET_RECRUITING

    Tainan, Taiwan

  • National Taiwan University Hospital

    NOT_YET_RECRUITING

    Taipei, Taiwan

  • Pindara Private Hospital

    COMPLETED

    Benowa, Queensland, Australia

  • Q Medical Conselling

    WITHDRAWN

    Perth, Washington, 6009, Australia

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • The Alfred Hospital

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, Australia

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Xinxiang, Henan, 453100, China

  • The Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, Australia

  • The University of Kansas Hospital

    RECRUITING

    Fairway, Kansas, 66205, United States

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Wollongong Private Hospital

    COMPLETED

    Wollongong, New South Wales, Australia

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