NCT07476014尚未招募1 期
Early Clinical Study on the Use of Donor-derived EBV-specific T Cells for the Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions
研究概览
简要总结
This study is a single-arm, open-label, dose-escalation and expansion, prospective clinical trial. Subjects will be recipients of allogeneic hematopoietic stem cell transplantation, with a planned enrollment of 9 to 18 subjects, to evaluate the safety and efficacy of JYEST cell injection for the prevention of EBV infection after allogeneic hematopoietic stem cell transplantation.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;
- •Patients undergoing allogeneic hematopoietic stem cell transplantation with any of the following high-risk factors for EBV infection:
- •EBV-DNA is positive in the recipient's or donor's serum, whole blood, PBMC or sorted cells before allogeneic hematopoietic stem cell transplantation;
- •EBV-DNA is positive in the recipient's whole blood, PBMC or sorted cells after allogeneic hematopoietic stem cell transplantation, but EBV-DNA in plasma is negative;
- •Allogeneic hematopoietic stem cell transplantation is performed due to treatment of EBV infectious diseases, including but not limited to: EBV-related lymphoma, chronic active EBV infection, EBV-related lymphoproliferative disorders, etc.;
- •There is a history of EBV infection in the past, and allogeneic hematopoietic stem cell transplantation is required due to other malignant diseases.
- •No age or gender restrictions;
- •The subject and the guardian understand and sign the informed consent form.
排除标准
- •The exclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;
- •Exclusion criteria before infusion of JYEST cell injection:
- •Severe kidney disease (creatinine clearance rate less than 50% of the normal reference value for the same age group);
- •Severe liver disease (TBil > 2.0×ULN; ALT and AST > 3.0×ULN);
- •Severe acute infection (opportunistic infection);
- •Expected survival period less than 6 weeks;
- •Malnutrition (weight ≤ 10th percentile for the same age group, or serum albumin ≤ 3.0 g/dL);
- •ECOG score > 2.
研究组 & 干预措施
JYEST Cell Injection Infusion
Experimental
JYEST cell injection infusion
干预措施: JYEST Cell Injection Infusion (Biological)
结局指标
主要结局
The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions
时间窗: From CAR - T cell infusion to 28 days later
次要结局
- Incidence of Epstein-Barr virus (EBV) infection(From CAR - T cell infusion to 2 years later)
研究者
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