Overview

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).

Eligibility

Inclusion Criteria:

• 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:

1. 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
2. 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:

1. Antiviral treatment with ganciclovir or foscavir for 14 days
   • No Virus load decrease (≤ 1 log) or virus load increase on day 14
2. Or if > 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14

   days and CD3+ cells < 300/µL

3. Or if antiviral treatment is contraindicated -

Patient Exclusion Criteria:

• graft-versus-host disease (GVHD) > grade 2 at the time point of planned infusion
• Known allergy to iron-dextran or murine antibodies