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®

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Dec 9, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients who have had a hematopoietic stem cell transplant (HSCT) and are struggling with viral infections that don't respond to standard treatments. Specifically, researchers want to see if infusing special immune cells—called virus-specific T-cells—from a donor can help fight infections caused by adenovirus, cytomegalovirus (CMV), or Epstein-Barr virus (EBV). The study uses a technique known as the Cytokine Capture System® to prepare these immune cells, which has shown promise in previous studies.

To participate in this trial, you need to be an adult over 18 years old who has received an allogeneic HSCT (a transplant from a donor). You must also have ongoing viral infections that haven't improved despite treatment. For example, if you've been on antiviral medications but your viral levels haven't decreased, you may be eligible. If you join the study, you can expect to receive these donor-derived T-cells through an infusion, and the researchers will closely monitor your health to assess the treatment's safety and effectiveness. It's important to note that participants cannot have severe graft-versus-host disease (a condition where the donated cells attack the recipient's body) or allergies to certain treatments.

Gender

ALL

Eligibility criteria

• 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