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
Parallel
Pivekimab Sunirine
DrugIntravenous
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation
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)
Maximum observed serum/plasma concentration of intact ADC.
Cmax of FGN849 Payload
Maximum observed serum/plasma concentration of FGN849 payload.
Area Under the Concentration-Time Curve (AUC) of Intact ADC
Area under the concentration-time curve of intact ADC.
Percentage of Participants Achieving Complete Remission (CR)
CR is defined as Hematologic recovery: Absolute Neutrophil Count (ANC) \> 1.0 × 10\^9/L (\> 1,000/μL) and platelet count \> 100 × 10\^9/L (\> 100,000/μL); \< 5% bone marrow blasts; absence of circulating blasts; no evidence of extramedullary disease; no transfusions or support by exogenous growth factors (GCSF) within 7 days prior to response evaluation.
Percentage of Participants Achieving Composite Complete Remission (CR + complete remission with incomplete recovery [CRi])
Percentage of participants achieving CR + CRi.
Percentage of Participants Achieving Composite Complete Remission (CR + complete remission with partial hematological [CRh])
Percentage of participants achieving CR + CRh.
Duration of Complete Remission (DOCR)
DOCR is defined as the first response of CR to the time of relapse or death from any cause, whichever comes first; for participants who did not relapse or die, the duration will be censored at the time of the last response assessment.
