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Prospective, Open, Randomized, Two-arm, Controlled, Multicenter Clinical Phase I/IIa Trial to Evaluate the Safety and Efficacy of Adoptive Immunotherapy With Allogeneic CMV/EBV Specific, Peptide Stimulated T-cells (CD3+) for Prevention or Preemptive Therapy of Reactivation of CMV and/or EBV in Patients After Allogeneic, HLA Identical Stem Cell Transplantation
In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening complication requiring antiviral treatment. The underlying problem is a severe suppression of the donors immune system after transplantation into the patient. Herpesviruses such as CMV and EBV persist after primary infection life long in the host and therefore require constant immunological control. This control is largely provided by the T-cell compartment of the immune system. After allogeneic stem cell transplantation the T-cell compartment requires a long time for its reconstitution since only a small fraction of the donor T-cells are transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell control. This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a phase I study to demonstrate that these in vitro generated T-cells can be applied safely in this patient population. The study also aims at demonstrating the efficacy of CMV/EBV specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host disease and that they successfully prevent reactivation of CMV and EBV after adoptive transfer in patients after allogeneic stem cell transplantation.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Medical Center Augsburg
Augsburg, Germany
Charité University Hospital Berlin
Berlin, Germany
Universitiy Hospital Erlangen
Erlangen, Germany
University of Mainz
Mainz, Germany
University of Munich LMU
Munich, Germany
University of Regensburg
Regensburg, Germany
Start Date
October 1, 2014
Primary Completion Date
October 1, 2016
Completion Date
March 1, 2017
Last Updated
December 14, 2020
50
ACTUAL participants
CMV/EBV specific T-cell
BIOLOGICAL
Lead Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Data Source & Attribution
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