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New hope for kids with tough leukemia: experimental drug enters human testing

NCT ID NCT07306832

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 12 times

Summary

This early-stage study is testing an experimental drug called pivekimab sunirine in about 18 children whose acute myeloid leukemia (AML) has come back or not responded to standard treatments. The main goals are to check the drug's safety and how it moves through the body. Participants will receive the drug by IV, and researchers will monitor side effects and any signs that the leukemia is responding.

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

About 18 people

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

Started

May 2026

Expected to finish

Mar 2030

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

6 months to 17 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: * Must have histologically confirmed acute myeloid leukemia (AML) meeting one of the following disease criteria: * Second or greater relapse. OR * Disease refractory to second or subsequent line of therapy (defined as resistant disease after at least one cycle of each treatment regimen). * Must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution. * Has \>= 5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study. * Performance status by Lansky (\< 16 years old at evaluation) or Karnofsky (\>= 16 years old at evaluation) score \>= 50 or ECOG score \<= 2. * May have status of central nervous system (CNS)1, CNS2, or CNS3 disease without clinical signs or neurologic symptoms suggestive of CNS leukemia, such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome. Participants receiving intrathecal therapy and no additional CNS-directed systemic therapy at study entry are eligible and may continue treatment as clinically indicated in accordance with institutional practice. * For those participants who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide informed consent and participant willing and able to give assent, as appropriate for age and country. Exclusion Criteria: * Known clinically significant cardiac disease. * Down syndrome. * Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML). * Symptomatic central nervous system (CNS3) disease * Prior history of any severity veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) of the liver. * Prior history of hematopoietic stem cell transplant within 6 months prior to Screening without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either post-transplant graft-versus-host disease (GvHD) or post-transplant rejection (except for a stable dose of corticosteroids). * Have received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy. * Any other known current malignancy requiring therapy. * Currently receiving anticancer therapy with antineoplastic intent, including radiotherapy, systemic therapy small molecules, monoclonal antibodies, other investigational agents, or high-dose chemotherapy with the exception of intrathecal therapy.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia Recurrence

As listed by the trial registrant

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

Acute myeloid leukemia

How to take part

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

  1. The places running it

    13 sites in 7 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

  • Cambridge University Hospital /ID# 277041

    RECRUITING

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Children's Medical Center Dallas /ID# 275930

    RECRUITING

    Dallas, Texas, 75235, United States

  • Chu Bordeaux - Hopital Pellegrin /ID# 277645

    RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Hopital Armand Trousseau /ID# 276231

    RECRUITING

    Paris, 75571, France

  • Lucile Packard Children's Hospital /ID# 276015

    RECRUITING

    Palo Alto, California, 94304, United States

  • National Taiwan University Hospital /ID# 276635

    RECRUITING

    Taipei, 100, Taiwan

  • New York Medical College /ID# 275597

    RECRUITING

    Valhalla, New York, 10595, United States

  • Ospedale Pediatrico Bambino Gesu /ID# 275692

    RECRUITING

    Rome, Roma, 00165, Italy

  • Perth Children'S Hospital /ID# 275673

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • Samsung Medical Center /ID# 276979

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 276978

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • The Children's Hospital at Westmead /ID# 275672

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Tristar Centennial Medical Center /ID# 275831

    RECRUITING

    Nashville, Tennessee, 37203, United States

More trials for these conditions

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