A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
研究概览
简要总结
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
详细描述
A multiple centers, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD
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
- 4 Years 至 70 Years（Child, 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); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance;
排除标准
- •Accepted systemic or local treatment of mesenchymal stem cells;
- •Have severe allergy to blood products or have allergy history of heterologous protein;
- •Expected survival period within 3 months;
- •Alanine transaminase(ALT)or Aspartate aminotransferase(AST)>2*upper limit of normal(ULN);Creatinine clearance rate≤30ml/min or Blood Urea Nitrogen(BUN)>2*upper limit of normal(ULN), International Normalized Ratio (INR)>1.5*upper limit of normal(ULN);
- •Have severe hepatic veno-occlusive disease(HVOD);
- •Have severe lung disease like severe lung infection;
- •Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;
- •Proved having resistant hypertension within 6 months before enrollment;
- •Have active thrombus;
- •Have untreated or uncertain active solid tumors within 5 years;
- •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;
- •Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;
- •Have active hepatitis B or hepatitis C;
- •Have gastrointestinal symptoms which not caused by GVHD
- •Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;
- •Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;
- •Not suitable for this clinical trial for other reasons.
研究组 & 干预措施
iMSC injection
Low dose injection once a week; Low dose injection twice a week; High dose injection once a week; High dose injection twice a week;
干预措施: iMSC (Biological)
结局指标
主要结局
Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
时间窗: From the date of initial infusion to 180 days after initial infusion
Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0
Dose-Limiting Toxicity(DLT)
时间窗: 4 weeks after initial infusion
Number of Dose-limiting toxicity in 28 days after injection
次要结局
- Overall Survival(OS)(100 days after initial infusion)
- Objective Response Rate(ORR)(28 days after initial infusion)
研究者
Xiaoyu Zhu
Chief physician
Anhui Provincial Hospital