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®
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®
University Hospital, Basel, Switzerland
30 participants
Dec 1, 2014
INTERVENTIONAL
Conditions
Summary
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 Criteria19
- 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 -
Exclusion Criteria2
- graft-versus-host disease (GVHD) \> grade 2 at the time point of planned infusion
- Known allergy to iron-dextran or murine antibodies
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02007356