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®
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).
• 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:
• 1\. 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 -