The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem cell transplant (HSCT) with virus-specific, antigen-selected T-cells, selected using the CliniMACS prodigy system. Secondary Objective(s) * To describe the safety profile of the infusion of CMV- specific, antigen selected T-cells. * To describe the toxicities related to infusion of CMV- specific, antigen selected T-cells. * To describe the rate of eradication of opportunistic CMV infections after HSCT and and treatment with CMV-specific, antigen-selected T-cells using the CliniMACS Prodigy System. This feasibility study will include a single treatment cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
It is expected that the cell dose will be in the range of 10\^3 - 10\^5 virus - specific, antigen selected T cells per kg of recipient weight.
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGIncidence of adverse events
To determine the feasibility of the intervention, the study will record the incidence of adverse events, including graft versus host disease and other complications will be evaluated using binomial distribution theory and their 95% confidence intervals (CIs) will be also estimated using Wilson's method
Time frame: Up to 100 days after transplant
Eradication rate of opportunistic CMV infections
The eradication rate will be the disappearance of opportunistic CMV infections with the use of CMV-specific, antigen-selected T cells using the CliniMACS Prodigy System over the total number CMV infections.
Time frame: Up to 100 days after transplant
response rate
A response rate of 25% is considered unacceptable; and the anticipated response rate is approximately 55% for the study population using the cell therapy.
Time frame: Up to 100 days after transplant
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