Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R/R) AML.
Pivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world.
Participants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
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.
Known clinically significant cardiac disease.
Down syndrome.
Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
Symptomatic central nervous system (CNS3) disease