Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants
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|ClinicalTrials.gov Identifier: NCT00674648|
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : March 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections||Biological: CMV-Peptide-Specific T cells||Phase 1|
Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 2007|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
This is a non-randomized single institution phase I dose escalation trial, designed to evaluate the toxicity and anti-viral activity of CMV-pp65 peptide-specific T cell lines, generated in vitro from CMV seropositive normal HSCT and 3rd party donors, when adoptively transferred to treat recipients of these transplants who have a CMV infection or persistent CMV antigenemia and are therefore at high risk of a life-threatening CMV infection.
Biological: CMV-Peptide-Specific T cells
In this phase I trial, five escalating dose levels will be tested. Each dose will be administered to groups of at least 3 and up to 6 patients. Dose escalation will be based on the dose limiting toxicity (DLT) observed in each treatment group (Confer Biostatistics).
The patient groups and donors are outlined as follows: Group I will receive a single dose of 5 x 105 T cells/kg body weight/dose; Group II will receive a single dose of 1 x 106 T cells/kg/dose; and group III will receive a single dose of 2 x 106 T cells/kg/dose; group IV will receive 3 weekly doses of 1 x 106 T cells/kg/dose; group V will receive 3 weekly doses of 2 x 106 T cells/kg/dose.
- To assess the safety or toxicities of escalating doses of donor-derived CMV-pp65 peptide-specific T cells. [ Time Frame: conclusion of the study ]
- To quantitate alterations in the level of CMV antigenemia in the blood of patients with either active infection or persistent antigenemia following adoptive transfer of CMV-pp65 peptide-specific T cells. [ Time Frame: conclusion of the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674648
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Susan Prockop, MD||Memorial Sloan Kettering Cancer Center|