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Pivekimab Sunirine for Pediatric Relapsed or Refractory AML

This study is looking at a drug called pivekimab sunirine for children and teenagers (ages 6 months to 17 years) who have acute myeloid leukemia (AML), an aggressive blood cancer. This is for patients whose AML has come back after treatment (relapsed) or hasn't responded to treatment (refractory). The main goals are to see what side effects pivekimab sunirine causes and how it moves through the body. About 18 participants worldwide will receive pivekimab sunirine through an IV (into a vein). Success in this study means understanding the safety of the drug and how it's processed by the body, with side effects leading to stopping treatment being measured for up to 24 months.

Study design
This is an open-label, single-arm study, meaning all participants will receive pivekimab sunirine, and everyone involved will know what treatment is being given. Around 18 pediatric participants will be enrolled.
What's involved
Participants will receive pivekimab sunirine intravenously (IV). The study will assess side effects and how the drug moves through the body for up to approximately 22-24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events for up to approximately 24 months, and drug levels in the body will be measured for up to approximately 22 months.

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NCT07306832

A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Recruiting
PHASE1Ages 6–17InterventionalTreatment
AbbVie
~18 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Pivekimab Sunirine

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation
Measured over Up to Approximately 24 Months
+6 more outcomes measured

Conditions

Acute Myeloid Leukemia

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Where it's being run

12 sites across 11 states
Seoul Teugbyeolsi2
California1
New York1
Tennessee1
Texas1
New South Wales1
Western Australia1
New Aquitaine1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment DiscontinuationUp to Approximately 24 Months

    Number of participants with protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with pivekimab sunirine (PVEK). Severity of TEAEs will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

  • Maximum Observed Serum/Plasma Concentration (Cmax) of Intact Antibody-Drug Conjugate (ADC)Up to Approximately 22 Months

    Maximum observed serum/plasma concentration of intact ADC.

  • Cmax of FGN849 PayloadUp to Approximately 22 Months

    Maximum observed serum/plasma concentration of FGN849 payload.

  • Area Under the Concentration-Time Curve (AUC) of Intact ADCUp to Approximately 22 Months

    Area under the concentration-time curve of intact ADC.

  • AUC of FGN849 payloadUp to Approximately 22 Months

    Area under the concentration-time curve of FGN849 payload.

  • Time to Cmax (Tmax) of Intact ADCUp to Approximately 22 Months

    Time to Cmax of intact ADC.

  • Tmax of FGN849 PayloadUp to Approximately 22 Months

    Time to Cmax of payload.