A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- Incidence of Response to Treatment (Efficacy)
研究概览
简要总结
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.
Funding Source: FDA OOPD
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
- 1 Month 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
patients with adenoviral infection
patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.
干预措施: cytotoxic t-lymphocytes (Drug)
结局指标
主要结局
Incidence of Response to Treatment (Efficacy)
时间窗: 12 weeks after last infusion
Patients will be followed for improvement in viral infection by monitoring ADV PCR weekly for response to treatment with CTLs
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 12 weeks after each infusion
Patients will be followed for adverse events following each infusion of ADV CTLs
次要结局
未报告次要终点
研究者
Mitchell Cairo
Principal Investigator
New York Medical College