A 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®
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT02007356, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Basel, Switzerland
- Trial code
- NCT02007356
- Record updated
- 20 March 2025
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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 -; 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.