An Initial Study Where Doctors Use Specific Immune Cells From Partially Matched Donors to Treat Severe Adenovirus Infections in Hospitalized Patients
Phase: Recruiting
First Posted: February
Condition(s): Adenovirus
NCT Number: NCT04722029 Other Study ID Number(s): adV VSTS
What Is the Purpose of This Study?
This study will test the safety and effectiveness of using specific immune cells from related donors to treat adenovirus infections. These immune cells will be taken from blood samples and prepared using a special machine and process to make them more effective.
Who Can Take Part in This Study?
People who may be eligible for this study are ages 0 days to 60 years with one of these conditions:
- Had an organ transplant (like kidney or heart) more than 28 days ago.
- Have cancer and got chemotherapy in the last 6 months.
- Have an autoimmune condition not linked to immune deficiency.
- Got immunosuppressive treatments (like certain drugs) in the last 30 days.
- No known immune system issues.
For a full list of eligibility requirements, visit https://clinicaltrials.gov/study/NCT04722029
What Will Happen During This Study?
- Qualified donors will have their blood collected through leukapheresis. This process will last up to 2 hours or until 2 blood volumes are collected, whichever happens first.
- Qualified patients will get an infusion of ADV-VSTS cells from partially matched donors. After the infusion, all patients will be monitored to see how they respond in lab tests and clinical settings, and to check for safety, effectiveness and tolerance.
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What Parents Need to Know About Adenovirus
Adenovirus infections peak in winter and spring; but unlike the flu, they remain common throughout the year. These viruses cause about 10 percent of all childhood fevers, and nearly every child has had at least one adenovirus infection by 10 years of age.
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