A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)

AbbVie14 个研究点分布在 7 个国家目标入组 18 人开始时间: 2026年5月20日最近更新: 2026年9月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 18
试验地点: 14
主要终点: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 6 Months 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•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 <=
•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.

排除标准

•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.

研究组 & 干预措施

Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years

Experimental

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

干预措施: Pivekimab Sunirine (Drug)

Cohort 1: Pivekimab Sunirine Ages 2 to < 6 Years

Experimental

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. If enrolled, subjects aged 6 months to less than 2 years will be included in Cohort 1

干预措施: Pivekimab Sunirine (Drug)

Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years

Experimental

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

干预措施: Pivekimab Sunirine (Drug)

结局指标

主要结局

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation

时间窗: Up 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)