NCT05863234招募中1 期
Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)
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
- 7
- 试验地点
- 1
- 主要终点
- Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)
研究概览
简要总结
This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.
排除标准
- •Patients eligible to receive chemotherapy as treatment for ANKL
研究组 & 干预措施
Treatment with PPMX-T003
Experimental
干预措施: PPMX-T003 (Drug)
结局指标
主要结局
Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)
时间窗: 7days after the administration
In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the first course, incidence of AEs and DLTs by the treatment are measured.
次要结局
- Efficacy of PPMX-T003 repeated continuous intravenous administration (2) improvement in liver function as assessed by the Model for End-stage Liver Disease (MELD and MELD-Na)(35 days)
- Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy(35days after the treatment)
- Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan(35 days)
- Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months(6 months)
- Anti-drug antibody production (Immunogenicity)(35 days)
- Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)(From the second course to the final course (Max. 35days after the first administration))
- Serum drug concentration during repeated continuous intravenous PPMX-T003 administration(35 days)
研究者
研究点 (1)
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