Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant
Mari Dallas
Summary
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).
Description
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-specif…
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration * Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met) * Patients may have asymptomatic viremia (\>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND * Patients must have ONE OF THE NEXT FOUR CRITERIA: * Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclov…
Interventions
- BiologicalCMV specific adoptive t-cells
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.
Location
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio