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Antigen Specific Adoptive T Cell Therapy for Refractory Opportunistic Adenovirus Infection After a Hematopoietic Stem Cell Transplantation
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).
Details
| Lead sponsor | Mari Dallas |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | RECRUITING |
| Enrolment | 20 |
| Start date | 2019-01-04 |
| Completion | 2028-12 |
Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
Interventions
- IFN-gamma-secreting HAdV antigen specific T cells
Primary outcomes
- Number of patients with severe adverse events — Up to 100 days after infusion
This is a measure of feasibility: Severe adverse events are related to the infusion of virus-specific, antigen selected T cells, Grade ≥ 3 acute graft versus host disease,• Death within 30 days of the infusion of the virus-specific, antigen selected T cells that is considered by the investigators to be probably or possibly related to the T cell infusion
Countries
United States