Preventative/Preemptive Adoptive Transfer of Peptide Stimulated CMV/EBV Specific T-cells in Patients After Allogeneic Stem Cell Transplantation

Summary

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.

Conditions

• Patients Undergoing Allogeneic Stem Cell Transplantation

Interventions

BIOLOGICAL

CMV/EBV specific T-cell

Peptide stimulated allogeneic T-cells with dual specificity for CMV and EBV

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University of Regensburg

  collaborator OTHER

• Johannes Gutenberg University Mainz

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• BayImmuNet Bavarian Immunotherapy Network

  collaborator UNKNOWN

• German Research Foundation

  collaborator OTHER

• University of Erlangen-Nürnberg Medical School

  lead OTHER

Principal Investigators

• Armin H Gerbitz, MD, PhD · Charite University, Berlin, Germany

• Bernd Spriewald, MD, PhD · University Hospital Erlangen

• Anita Kremer, MD,PhD · University Hospital Erlangen

• Katja San Niccolo, MD · University Hospital Erlangen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-10-31

Completion

2017-03-31

Countries

• Germany

Study Locations