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Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C)

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Contents

clinicaltrials.gov/study/NCT02313857
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT023138570
Trial Recruitment Size
100
Trial Sponsor
AlloVir
AlloVir
0
Clinical Trial Start Date
2015
0
Primary Completion Date
2017
0
Study Completion Date
2018
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Intervention Name
Viralym-C0
Interventional Trial Phase
Phase 10
Official Name
A Phase I Study Using Most Closely HLA-matched Cytomegalovirus-specific T Lymphocytes for the Treatment of Cytomegalovirus Infections Post-allogeneic Stem Cell Transplant(VIRALYM-C)0
Last Updated
December 26, 2018
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections. CMV can cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes. Investigators want to see if they can use a kind of white blood cell called T cells to treat CMV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated CMV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target CMV. In this study, investigators want to find out if the banked CMV-specific T cells derived from healthy donors are safe and can help to treat CMV infection. The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food and Drug Administration (FDA).

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