Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- Successful production of viral specific T-cells
研究概览
简要总结
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
详细描述
Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.
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
- 2 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunocompromised patient with evidence of viral infection or reactivation
- •Age >1 day
- •Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
- •Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
- •Must be able to receive CTL infusion in Cincinnati
- •Informed consent obtained by PI or sub-investigator either in person or by phone
排除标准
- •Active acute GVHD grades II-IV
- •Uncontrolled bacterial or fungal infection
- •Uncontrolled relapse of malignancy requiring treatment with chemotherapy
- •Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
- •Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
研究组 & 干预措施
Viral Specific VST Infusion
3rd party VST infusion
干预措施: Viral Specific VST Infusion (Biological)
结局指标
主要结局
Successful production of viral specific T-cells
时间窗: Within 30 days post culture initiation
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Percentage of patients who do not have infusional toxicity
时间窗: Through 30 minutes post infusion
Patients will be monitored for infusional toxicity
Incidence of GVHD associated with VST infusion
时间窗: Through 30 days after infusion
Patients will be monitored for the development of VST associated GVHD
次要结局
- Presence of viral-specific T-cells(At 30 days after infusion)
- Viral burden(At 30 days after infusion)