NCT04197596招募中1 期
A Pilot Study in the Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 11
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
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
- •.1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either
- •Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
- •Medical intolerance to anti-viral therapies including:
- •2 renal toxicity with cidofovir or other > grade 2 toxicities secondary to cidofovir And/or
- •known resistance to cidofovir 1.
- •Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
- •1.3 Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test
排除标准
- •Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion
- •Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
- •Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
- •Thymoglobulin (ATG) or Alemtuzumab within 30 days
- •Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30%
- •Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection.
- •Any medical condition which could compromise participation in the study according to the investigator's assessment
- •Known HIV infection
- •Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
- •Known hypersensitivity to iron dextran
- •Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- •Known human anti-mouse antibodies
研究组 & 干预措施
BK CTL
Experimental
Eligible patients with refractory BK infection will receive up to 20 infusions of BK CTLs that are donor derived.
干预措施: BK CTL (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 12 weeks
Patients will be monitored for adverse events following each CTL infusion
次要结局
未报告次要终点
研究者
研究点 (11)
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