NCT06941350尚未招募1 期
A Phase I/II Clinical Study Evaluating the Safety and Efficacy of NCR102 Injection in the Treatment of Acute Graft-versus-Host Disease (aGVHD)
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Adverse Event(AE) or Serious Adverse Event(SAE)
研究概览
简要总结
Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.
详细描述
An open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.
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
- •Age>18 years and <70 years old (including threshold), gender not limited；
- •Grade II to IV gastrointestinal involvement acute graft-versus-host disease(aGVHD)；
- •Subjects with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)；
- •Failed to second-line aGVHD treatment;
- •Subjects will receive NCR102 injection treatment within 3 days after enrollment;
- •Voluntarily sign an informed consent form.
排除标准
- •Subjects have lung disease, and investigators have determined that they are not suitable for the study;
- •Subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome;
- •Subjects with signs/symptoms of chronic GVHD;
- •Subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (CMV) enteritis, transplant related thrombotic microvascular disease (TA-TMA), or digestive tract infection;
- •Eastern Cooperative Oncology Group(ECOG)>3；
- •Subjects have other diseases or physiological conditions that may interfere with the evaluation results of this trial, or life-threatening complications；
- •Subjects had active malignant solid tumors within the past 5 years；
- •Subjects had a known history of severe allergies to blood products, or heterologous proteins.
研究组 & 干预措施
NCR102 injection
Experimental
Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection
干预措施: NCR102 injection (Biological)
结局指标
主要结局
Adverse Event(AE) or Serious Adverse Event(SAE)
时间窗: 100 days after first administration of NCR102 injection
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
次要结局
- ORR at Day 28(28 days after first dose administration)
- CRR at Day 28(28 days after first dose administration)
- ORR at Day 56(56 days after first dose administration)
研究者
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