Antigen Specific Adoptive T Cell Therapy for Refractory Opportunistic Adenovirus Infection After a Hematopoietic Stem Cell Transplantation
Mari Dallas
Summary
The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy. Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into 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
Brief Background/Rationale: This study seeks to determine the feasibility of using antigen specific T cells isolated with the CliniMACS® Cytokine Capture System (CCS) for the treatment of adenovirus infections occurring after allogeneic Hematopoietic Stem Cell Transplantation (HSCT). Primary Objective: To determine the feasibility of the treatment of opportunistic adenovirus infection after HSCT with adenovirus-specific, antigen-selected T cells, using the CliniMACS® Prodigy System. Exploratory Objective(s) * To describe the safety profile of the infusion of virus - specific, antigen select…
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration. * Patients must have evidence of documented HAdV infection/reactivation. Patients may be: * Symptomatic with any detectable viral load OR * Asymptomatic with viral load that is: \>1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens * Patients must have poor response and/or contraindication to therapy: * Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of an…
Interventions
- BiologicalIFN-gamma-secreting HAdV antigen specific T cells
Antigen selected cells will be obtained using the CliniMACS(R) Prodigy System from a compatible donor. Isolated cells will be infused into the donor to treat human adenoviral infection after transplant
Location
- University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio