A Phase I/II Single-center Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Level of enriched IFN-γ+ T-cells
研究概览
简要总结
To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years of age
- •Undergone allogeneic HSCT
- •Written informed consent
- •Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:
- •Patient with Adenovirus Infection:
- •Antiviral treatment with cidofovir for at least 7 days
- •no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or
- •cluster of differentiation 3 (CD3) + cells < 300/µL on treatment for at least 7 days
- •Or if antiviral treatment is contraindicated
- •Patient with EBV:
- •After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg/m2)
- •No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or
- •CD3+ cells < 300/µL 7 days after receipt of treatment or
- •Clinical progression
- •Patient with CMV:
- •Antiviral treatment with ganciclovir or foscavir for 14 days
- •No Virus load decrease (≤ 1 log) or virus load increase on day 14
- •Or if > 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells < 300/µL
- •Or if antiviral treatment is contraindicated -
排除标准
- •graft-versus-host disease (GVHD) > grade 2 at the time point of planned infusion
- •Known allergy to iron-dextran or murine antibodies
研究组 & 干预措施
allogeneic HSCT
The present study will evaluate and validate in a single-center, open-label, single arm fashion the safety and feasibility of direct infusions of donor-derived pathogen-specific IFN-γ positive T-cells in recipients of HSCT with post-transplant viral infection according to the previously clinically certified CCS® [3-6]. The Investigator will first generate and apply IFN-γ positive selected T-cells to recipients of HSCT with CMV, EBV or adenovirus as previously published. The Investigator aim is to include 6 patients from the University Hospital of Basel.
With confirmed safety the investigator will in the future perform an efficacy study and extend this treat-ment for other clinically relevant pathogens including human herpesvirus (HHV)-6, HHV-8, polyomaviruses JC and BK and fungi including Aspergillus fumigatus and Candida albicans, to other immunosuppressed patients such as solid organ transplant (SOT) recipients.
干预措施: IFN-γ positive selected T-cells (Biological)
结局指标
主要结局
Level of enriched IFN-γ+ T-cells
时间窗: 7 days
次要结局
- Treatment efficacy(7 days)