Clinical Trial: Most Closely Human Leukocyte Antigen (HLA)-Matched Adenovirus-specific T Lymphocytes (Viralym-A)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase I Study Using Most Closely HLA-matched Adenovirus-specific T Lymphocytes for the Treatment of Adenovirus Infections Post-allogeneic St

Brief 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.

Adenovirus (AdV) is a virus that just causes symptoms of a common cold normally, but which can cause serious life-threatening infections in patients who have weak immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the pancreas and the eyes.

Investigators want to see if they can use a kind of white blood cell called T cells to treat adenovirus 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 AdV-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 AdV.

In this study, investigators want to find out if the banked AdV-specific T cells derived from healthy donors are safe and can help to treat adenoviral infection.

The AdV-specific T cells (Viralym-A) are an investigational pr

Detailed Summary:

To make AdV-specific T cells (Viralym-A cells), small pieces of protein called peptides that come from AdV were mixed with blood cells from healthy donors. These peptides train a kind of white blood cell called T cells to recognize and kill cells that are infected with AdV. These T cells were then grown in special growth factors in special flasks in the lab. Once we made sufficient numbers of cells, we tested them to make sure they recognized cells infected by adenovirus, and then we froze them.

When we think the subject needs them, Viralym-A cells will be thawed and injected into the intravenous line. To prevent an allergic reaction, prior to receiving Viralym-A cells the subject may be given diphenhydramine (Benadryl) and acetaminophen (Tylenol). The subject will remain in the clinic for at least one hour after the infusion. After the subject receives the cells, the transplant doctor will monitor the levels of adenovirus in the blood. We will also take blood to see how long the cells we gave the subject are lasting in the body.

Subjects will continue to be followed by their transplant doctors after the injection. The subject will either be seen in the clinic or they will be contacted by a research nurse to follow up for this study every week for 6 weeks, then at 3, 6 and 12 months. The subject may have other visits for their standard care. Subjects will also have regular blood tests done to follow their counts and the viral infection as part of their standard care.

To learn more about the way Viralym-A cells are working in the body, an extra 30-40 ml (6-8 teaspoons) of blood will be taken before the infusion and then at study follow-up visits at 1, 2, 3, 4 and 6 weeks, and 3 months after the infusion. Blood should come from the central intravenous line, and should not req
Sponsor: ViraCyte

Current Primary Outcome: Assessment of patients with adverse events after Viralym-A infusion [ Time Frame: 42 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Assessment of adenoviral load response to the Viralym-A infusion [ Time Frame: 1 year ]
  Viral load over time within a patient will be visualized to reveal the temporal patterns of immune response. Plots of smooth curves will be generated for each patient to graphically illustrate the pattern and duration of T-cell changes.
• Reconstitution of antiviral immunity after Viralym-A infusion [ Time Frame: 3 months ]
  Reconstitution of antiviral immunity over time within a patient will be visualized to reveal the temporal patterns of immune response. Plots of smooth curves will be generated for each patient to graphically illustrate the pattern and duration of T-cell changes.

Original Secondary Outcome: Same as current

Information By: ViraCyte

Dates:
Date Received: October 20, 2014
Date Started: June 2017
Date Completion: December 2019
Last Updated: February 21, 2017
Last Verified: February 2017