A Study on Efficacy and Safety of iNK Cell Infusion in Patients With Chronic Active Epstein-Barr Virus Infection (CAEBV) and Epstein Barr Virus-induced Haemophagocytic Lymphohistiocytosis (EBV-HLH) After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Disease-free survival time (DFS)
研究概览
简要总结
To evaluate the efficacy and safety of iNK cells infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)
详细描述
It is a prospective, open-lable study to evaluate the efficacy and safety of iNK cell infusion in CAEBV/EBV-HLH patients after allo-HSCT. The study will enroll fifteen subjects who will receive ongoing least 4 doses of iNK cells intravenously infusion after allogeneic hematopoietic stem cell transplantation. All subjects will assess the incidence of disease relapse and EBV-DNA reactivation up to one year.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CAEBV or EBV-HLH who are eligible for allogeneic hematopoietic stem cell transplantation meet one of the following criteria:
- •①EBV-DNA (PBMC or plasma) was still more than 103 before transplantation；②Positive for Cerebrospinal fluid EBV-DNA；
- •③Abnormal phenotypic lymphocytes could still be detected in bone marrow immunotyping；
- •④Measurable EBV-related lesions on imaging；
- •≤65 years，ECOG :0-2；
- •Cardiac EF≥40%, creatinine clearance ≥50%; aminotransferase（ALT/AST）<200U/L。；
- •In patients with HLH, HLH efficacy ≥Partial Response after prior treatment is required；
- •Estimated survival time is longer than three months；
- •Agree to sign the Informed Consent Form。
排除标准
- •Patients with evidence of grade II or more serious heart disease according to the New York Heart Association (NYHA) score (including Grade II) ; Clear diagnosis of cirrhosis；
- •Active infections other than EBV that have not yet been controlled；
- •Positive for hepatitis B virus or hepatitis C virus；
- •Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.)；
- •Also participation in other interventional clinical studies within 4 weeks
研究组 & 干预措施
iNK cells infusion patients
Given iNK cell infusion after allo HSCT
干预措施: NCR300（Allogenic Ipsc-derived Natural Killer cells ） (Other)
结局指标
主要结局
Disease-free survival time (DFS)
时间窗: 1 year
Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels
Recurrence rate (RT)
时间窗: 1 year
EBV-DNA reactivation rate for high-risk patients
complete remission rate (CR)
时间窗: 1 year
EBV-DNA negative rate in relapsed/non-remitting patients
次要结局
- Adverse Event（AE）(1 year)
- cytomegalovirus DNA(1 year)