Most Closely Human Leukocyte Antigen (HLA)-Matched BK Virus-specific T Lymphocytes (Viralym-B)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02313844|
Recruitment Status : Withdrawn (Not developing product)
First Posted : December 10, 2014
Last Update Posted : April 9, 2018
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.
BK virus (BKV) is a virus that can cause serious life-threatening infections in patients who have weak immune systems. It affects the urinary tract, and can cause frequent urination, blood in the urine, and severe pain.
Investigators want to see if they can use a kind of white blood cell called T cells to treat BKV 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 BKV-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 BKV.
In this study, investigators want to find out if the banked BKV-specific T cells derived from healthy donors are safe and can help to treat BK virus infection.
The BKV-specific T cells (Viralym-B) are an investigational product not approved by the Food and Drug Administration (FDA).
|Condition or disease||Intervention/treatment||Phase|
|BK Virus Infection||Biological: Viralym-B||Phase 1|
To make BKV-specific T cells (Viralym-B cells), small pieces of protein called peptides that come from BKV 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 BKV. 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 BK virus, and then we froze them.
When we think the subject needs them, Viralym-B cells will be thawed and injected into the intravenous line. To prevent an allergic reaction, prior to receiving Viralym-B 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 BK virus 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-B 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 require extra needle sticks.
All participants on this study will be infused with the same number (dose) of cells. If Viralym-B infusion has helped the subjects infection or if they have had a treatment, for example with steroid drugs that might have destroyed the T cells the subject was given, then they are allowed to receive up to 4 additional infusions of the Viralym-B cells at the same initial dose level from 28 days after their initial infusion. Following infusions should be at least 14 days apart. After each Viralym-B cells infusion, subjects will be monitored as described above.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Using Most Closely HLA-matched BK Virus-specific T Lymphocytes for the Treatment of BK Virus Infections Post-allogeneic Stem Cell Transplant(VIRALYM-B)|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Partially HLA-matched Viralym-B cells will be thawed and given by intravenous injection. Patients will receive 2 x 10^7 partially HLA-matched Viralym-B/m2 as a single infusion.
If a patient has a partial response they are eligible to receive up to 4 additional doses at biweekly intervals. These doses would come from the original infused line if sufficient vials were available but may come from another line if there are insufficient cells in the original line.
Follow-up Assessments: The timing of follow-up visits is based on the date of Viralym-B infusion. If a patient has multiple Viralym-B infusions the schedule resets again at the beginning so follow up relates to the last Viralym-B infusion.
Follow up will occur at 7 days, 14 days, 21 days, 28 days, 42 days, 90 days, 180 days, and 365 days post enrollment.
- Assessment of patients with adverse events after Viralym-B infusion [ Time Frame: 42 days ]To determine if administration of banked BKV-specific T cells (Viralym-B) derived from healthy donors are safe in patients with BKV infection after allogeneic stem cell transplant.
- Assessment of BK viral load response to the Viralym-B 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-B 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313844
|United States, Texas|
|Texas Childrens Hospital|
|Houston, Texas, United States, 77030|
|The Methodist Hospital system|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Swati Naik, MD||Texas Childrens Hospital|
|Principal Investigator:||Bilal Omer, MD||The Methodist Hospital System|