An Exploratory Clinical Study of Multivirus-specific T Cells in the Treatment of Refractory Cytomegalovirus and/or Epstein-Barr Virus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 29
- 主要终点
- Assessment of safety and toxicity outcomes in subjects receiving VSTs infusion
研究概览
简要总结
To evaluate the safety and tolerability of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV).
Preliminary evaluation of the efficacy of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV); To monitor the duration and expansion of multi-virus VSTs cells after infusion.
详细描述
This study consists of two parts: (1) The first stage is the safety evaluation of multi-virus VSTs and the exploration of DLT and MTD; (2) The second phase is to evaluate the safety and efficacy of multi-viral VSTs in selecting appropriate doses in the first phase.
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
- 是
入选标准
- •Age ≥18 years old, and less than or equal to 70 years old, gender is not limited.
- •Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation.
- •Persistent infection with CMV and/or EBV persists despite standard treatment .
- •Prednisone or its equivalent hormone is less than or equal to 0.5 mg/kg/ day when enrolled.
- •ECOG score ≤3, expected survival greater than 3 months.
- •End blood oxygen saturation ≥90% on room air.
- •Available multi-virus-specific cytotoxic T lymphocytes.
- •Negative pregnancy test in female patients if applicable.
- •Written informed consent and/or signed assent line from patient, parent or guardian.
排除标准
- •Within 28 days after allogeneic hematopoietic stem cell transplantation.
- •Active III-IV acute GVHD, and/or moderate and above chronic GVHD.
- •Severe organ dysfunction: Heart: New York Heart Association (NYHA) levels III and IV; Liver: Total bilirubin>34umol/l; ALT, AST>2 times the normal upper limit; Kidney: Blood creatinine >130umol/L; Lung: Type I or II respiratory failure; Brain: unconsciousness, intracranial hypertension.
- •Received DLI, other CTL, CAR-T, NK and other cell therapies, T cell monoclonal antibody immunosuppressants, or participated in any other clinical research related to drugs and medical devices within 28 days before enrollment.
- •Poor compliance, and subjects deemed unsuitable for study participation by the investigator.
结局指标
主要结局
Assessment of safety and toxicity outcomes in subjects receiving VSTs infusion
时间窗: within 56 days after the first VSTs infusion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, and graft-versus-host-disease will be summarized using descriptive statistics for each dose level
Assessment of antiviral efficacy of VSTs infusion
时间窗: within 56 days after the first VSTs infusion
Antiviral efficacy including clinical signs of viral infections, virus reinfection, and laboratory measurement of viral load after VSTs infusion will be determined
次要结局
- Virus-specific immune reconstitution(within 56 days after the first VSTs infusion)
研究者
Xiao-Jun Huang
Professor
Peking University People's Hospital