EUCTR2020-004725-23-GR进行中（未招募）1 期
Administration of rapidly generated multipathogen-specific T-Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus fumigatus infections post Allogeneic Stem Cell Transplant - Penta-STs-001
Ge???? ??s???µe?? Tessa??????? Ge?????? ?apa????????0 个研究点目标入组 10 人开始时间: 2022年9月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1)Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
- •2)Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ??V and AF (see 2.2.1 definitions).
- •3)Karnofsky/Lansky score of = 50.
- •4)ANC > 500/µl.
- •5)Bilirubin = 2x*, AST < 3x*, Serum creatinine = 2x*, Hemoglobin > 8.0 g/dl.
- •6)Pulse oximetry of > 90% on room air.
- •7)Available pentavalent-specific T cells.
- •8)Negative pregnancy test (if female of childbearing potential)
- •9)Patient capable of providing informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1)Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
- •2)Steroids > 0.5 mg/kg/day prednisone.
- •3)Received donor lymphocyte infusion in last 28 days.
- •4)GVHD = grade 2.
- •5)Active and uncontrolled relapse of malignancy.
- •6)Patients with other uncontrolled infections
研究者
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