CMV Infection Clinical Trial
Official title:
Therapeutic Infusion of Partially HLA-matched Third Party Donor-derived Virus- and Fungus Specific T-lymphocytes in Patients With Active Viral or Fungal Infection Post-allogeneic Stem Cell or Solid Organ Transplantation
To assess the safety and biological efficacy of therapeutically administered most closely HLA-matched third party donor-derived specific cytotoxic T lymphocytes (CTLs) targeting cytomegalovirus (CMV) or Adenovirus (Adv) or Epstein Barr virus (EBV) or fungi including Aspergillus and Candida species for the treatment of viral infection following allogeneic blood or marrow stem cell or solid organ transplantation.
The study will analyse the safety and biological efficacy of administering the
investigational products (most closely HLA-matched third party donor-derived T cells
stimulated with viral or fungal antigen expressing DC), for the treatment of viral
reactivation and/or infection or fungal infection following allogeneic blood or marrow or
solid organ transplantation. The cells will be given therapeutically after transplantation
in patients with active viral reactivation or proven/probably fungal infection despite
standard therapy.
Our AIMS are to study the safety of third party donor-derived CTL infusions, their effect on
treatment of viral reactivation as well as their effect on reconstitution of virus- and
fungus-specific immunity, viral and fungal infection and reactivation rates after
transplantation, viral load, and use of antiviral and antifungal pharmacotherapy.
We will evaluate the safety of infusions with respect to the development of adverse events
within the first 12 months post-CTL infusion and the dynamics of cell persistence by T-cell
chimerism analysis.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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