Actively Recruiting
Donor-Derived Viral Specific T-cells (VSTs)
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-12-16
750
Participants Needed
3
Research Sites
673 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
H
Hoxworth Blood Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant. The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death. Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find an easier way to treat these infections.
CONDITIONS
Official Title
Donor-Derived Viral Specific T-cells (VSTs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to 0.5mg/kg prednisone or other steroid equivalent
- Recipient must have achieved engraftment with ANC 26500
You will not qualify if you...
- Active acute GVHD grades II-IV
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy requiring chemotherapy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
2
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Completed
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
J
Jamie Wilhelm, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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