NCT06441084尚未招募1 期
A Phase I or II Clinical Trial Evaluating the Safety and Efficacy of NCR300 Injection in Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Adverse Event(AE) or Serious Adverse Event(SAE)
研究概览
简要总结
A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.
详细描述
This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF);
- •2.18-65years;
- •3.Clinical diagnosis of AML;
- •4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion;
- •5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD；
- •6.Have already recovered from the adverse reactions of previous treatment；
- •7.Having appropriate organ functions；
- •8.Eastern Cooperative Oncology Group(ECOG)<3;
- •9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study;
排除标准
- •Bone marrow examination shows hematological recurrence;
- •Have malignant tumors within 5 years before screening;
- •Subjects with acute promyelocytic leukemia(APL);
- •Subjects with severe respiratory diseases;
- •Subjects with clear history of neurological or psychiatric disorders in the past;
- •Active central nervous system involvement；
- •HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C;
- •Allergies to NCR300 or its excipients;
- •Subjects with active cardiovascular and cerebrovascular diseases;
- •Received organ transplantation or planned transplantation；
- •Received other treatment drugs after transplantation；
- •Graft-Versus-Host Disease (GVHD)>II grades;
- •Subjects with active nervous system autoimmune or inflammatory diseases;
- •Expected survival period within 3 months;
- •Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
- •Having mental illness；
- •Having uncontrollable active infections;
- •Subjects whose state is not suitable for entering the study;
- •Other situations determined by investigator that it is not suitable to enter the study.
研究组 & 干预措施
NCR300 injection
Experimental
Cohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection.
干预措施: NCR300 injection (Biological)
结局指标
主要结局
Adverse Event(AE) or Serious Adverse Event(SAE)
时间窗: From the date of initial infusion to a year after initial infusion
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Dose-Limiting Toxicity(DLT)
时间窗: 4 weeks after initial infusion
Number of participants with Dose-limiting toxicity in 28 days after first infusion
次要结局
- Maximum plasma concentration(Cmax)(2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.)
- Time after doing at which maximun plasma concentration is reached(Tmax)(2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.)
- Cumulative Incidence of Relapse(CIR)(6 Months After Initial Infusion)
- Minimal Residual Disease(MRD)(From the date of screening to a year after initial infusion)
研究者
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