Cytomegalovirus Infections Clinical Trial
Official title:
A Phase I Dose Escalation Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of CMV Infections Following Allogeneic Hematopoietic Stem Cell Transplants
The purpose of this study is to test the safety of a transfusion of specialized white cells
from your transplant donor's blood, called T-cells, that have been grown and immunized
against the CMV virus in the test tube. If the transplant donor is immune to CMV (ie: the
donor has antibody to CMV in the blood), the T-cells will be selected and grown from the
blood of the transplant donor. However, if the transplant donor is not immune to CMV, or if
T-cells from the donor are not readily available, CMV-immune T-cells grown from the blood of
another normal donor who is partially matched to the patients tissue type can be used. The
transplant physician will explain which of these treatments is available to the patient.
This trial is called a phase I trial because phase I trials are designed to test the safety
of different doses of an experimental treatment. We want to find out what effects, good
and/or bad, a dose/doses of these immune T-cells will have on the patient and on the CMV
infection.
Specifically, we wish to test CMV immune T-cells grown from your blood using a new method
developed at our center. In this method, fragments of an important CMV protein, called
CMVpp65, are chemically synthesized and then used to immunize T-cells in the test tube.
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