2024-520125-36-00招募中1 期
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 11
- 主要终点
- Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation
研究概览
简要总结
To determine the safety and pharmacokinetic profile of PVEK in pediatric subjects with relapsed/refractory CD-123-positive AML
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- Participants must have histologically confirmed 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)
- Participants must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.
- Participant 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.
- Participants may have status of CNS1, 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 may have non-CNS extramedullary disease.
排除标准
- Participant has known clinically significant cardiac disease.
- Participant with Down syndrome
- Participant has acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML)
- Participant has symptomatic central nervous system (CNS3) disease
- Participant has prior history of any severity VOD/SOS (veno-occlusive disease/sinusoidal obstructive syndrome) of the liver.
- Participants who have received prior CAR-T therapy
研究组 & 干预措施
PIVEKIMAB SUNIRINE
Test
干预措施: PIVEKIMAB SUNIRINE (Drug)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation
Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation
PK parameters for intact ADC and payload (FGN849), including Cmax, AUC, and Tmax
PK parameters for intact ADC and payload (FGN849), including Cmax, AUC, and Tmax
次要结局
- Composite Complete Remission (CR + CRh)
- Duration of Complete Remission (DOCR)
- Duration of Composite Complete Remission (CR + CRi)
- Duration of Composite Complete Remission (CR + CRh)
- Complete Remission (CR)
- Composite Complete Remission (CR + CRi)
研究者
研究点 (11)
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标识符
- 欧盟试验编号
- 2024-520125-36-00
- 其他研究编号
- M25-692
日期
- 首次发布
- (5个月前)
- 研究完成日期
- (3年后)
- 最近更新
- (2个月前)
监管与共享
- 是否有结果
- 否
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