PD-1 Antibody Improve Mixed Chimerism in Patients With Hemophagocytic Lymphohistiocytosis After Allo-HCT
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Chimeric rate
研究概览
简要总结
PD-1/PD-L1 pathway play an important role in Inhibiting the function of antigen-specific CD8+T cells, thus matter a lot in immune escape. We intend to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in patients after allo-HCT.
详细描述
Mixed chimerism is a trouble condition after allogeneic hematopoietic cell transplantation (Allo-HCT),all targeted treatment are aimed to improve the function of lymphocyte recipient. PD-1 antibody was reported to restored the function of impaired lymphocyte. Therefore, we want to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in HLH patients after allo-HCT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EBV-HLH according to the HLH-04 diagnostic criteria.
- •After allo-HCT, have achieved engraftment and reconstitute of hematopoiesis. have achieved full donor chimerism.
- •Withdraw immunosuppressive agent, chimeric rate was 80%-95%
- •Age >18 years old, gender is not limited.
- •no graft-versus-host disease was observed.
- •No secondary graft failure (ANC <0.5*10^9/l,PLT <10*10^9/l)
- •Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal. Serum creatinine ≤ 1.5 times the upper limit of Normal (ULN); No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.
- •Informed consent.
排除标准
- •Allergic to the test drug ingredients or to a more severe allergic constitution.
- •Chimeric rate continue to decline after 2 weeks of toripalimab Injection used.
- •Serious immunoreaction: myocardial damage, hepatitis, pneumonia.
- •Central nervous system symptoms.
- •Serious mental illness.
- •Active bleeding of the internal organs
- •Uncontrollable infection；
- •Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
- •Participate in other clinical research at the same time.
研究组 & 干预措施
PD-1 antibody for mixed chimerism
PD-1 antibody (Toripalimab Injection) used for mixed chimerism in HLH patients after allo-HCT
干预措施: Toripalimab Injection (Drug)
结局指标
主要结局
Chimeric rate
时间窗: 4 weeks after toripalimab injection was used
Chimeric rate in bone marrow or peripheral blood of HLH patients
次要结局
- treatment-related adverse events as assessed by CTCAE v5.0；(every 2 weeks after intervention, until 8 weeks after the use of PD-1 antibody)
研究者
Zhao Wang
principal investigator
Capital Medical University