NCT02048332RecruitingPhase 1/2
Donor-Derived Viral Specific T-cells (VSTs)
Donor-Derived Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Allogeneic Stem Cell Transplant
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 27 Jan 2014
- Start date
- Feb 2014
- Primary completion date
- Jan 2027
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- NCT number
- NCT02048332
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 1000
- From Feb 2014 to the primary completion date, Jan 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled relapse of malignancy requiring treatment with chemotherapy
Other illness
- Uncontrolled bacterial or fungal infection
Other
- Active acute GVHD grades II-IV
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
Who the study is looking for
- 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 ≥ 500
Age in the registry: 4 weeks to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akron Children's Hospital Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Completed |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.