Cytomegalovirus Infections Clinical Trial
— CCSOfficial title:
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsspital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Kaufmann GR, Khanna N, Weber R, Perrin L, Furrer H, Cavassini M, Ledergerber B, Vernazza P, Bernasconi E, Rickenbach M, Hirschel B, Battegay M; Swiss HIV Cohort Study. Long-term virological response to multiple sequential regimens of highly active antiretroviral therapy for HIV infection. Antivir Ther. 2004 Apr;9(2):263-74. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of enriched IFN-?+ T-cells | 7 days | ||
Secondary | Treatment efficacy | Treatment efficacy defined as reduction of virus load, in vivo expansion of antigen-specific T cells in peripheral blood as well as reduction of clinical signs of specific viral infection | 7 days |
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