A Phase 1 Study of CSL362 (Anti-IL3Rα / Anti-CD123 Monoclonal Antibody) in Patients With CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission With Incomplete Platelet Recovery at High Risk for Early Relapse
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Frequency and Severity of Adverse Events (AEs)
研究概览
简要总结
This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or older.
- •Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary.
- •Completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (CR)/CR with incomplete platelet recovery (CRp); either first or second CR.
- •Has factors conferring high risk of relapse.
- •No plans for additional post-remission chemotherapy.
- •Not currently a candidate for allogeneic hematopoietic stem cell transplant (HSCT).
排除标准
- •Diagnosis of acute promyelocytic leukemia (APL).
- •Known leukemic involvement of the central nervous system.
- •Life expectancy 4 months or less as estimated by the investigator.
- •Concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
结局指标
主要结局
Frequency and Severity of Adverse Events (AEs)
时间窗: From the first treatment (Day 1) up to approximately Day 106
Number of subjects reporting any AEs and the severity of those AEs.
Dose-limiting toxicity (DLT) evaluation
时间窗: From the first treatment (Day 1) up to approximately Day 106
Number of participants with DLT. Dose-limiting toxicity (DLT) is defined as: * A non-hematological toxicity grade 3 or worse. * A hematological toxicity grade 3 that does not recover to baseline within 14 days. * A hematological toxicity grade 4 or worse according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
次要结局
- Pharmacokinetic (PK) Parameters(Before each infusion and: at 6 time points within a week after infusion 1, at 1 time point within a week after infusions 2 to 5, at 5 time points within a week after infusion 6, and once at the final visit, approximately 5 weeks after infusion 6)
- Number of subjects developing antibodies against CSL362(From the first treatment (Day 1) up to approximately Day 106)