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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®

RecruitingPhase 2Ages 18 Years - 65 YearsAllUniversity Hospital, Basel, Switzerland
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • IFN-γ positive selected T-cells
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Where

1 site
Universitätsspital Basel
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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