Using donor-derived T-cells to treat viral infections after stem cell transplants
Official title: Donor-Derived Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Allogeneic Stem Cell Transplant
Run by Children's Hospital Medical Center, Cincinnati · NCT02048332 · Data updated 2026-11-12
This study is testing whether T-cells from stem cell donors can help patients who have infections after their transplants fight off those viruses.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 4 Weeks and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | alemtuzumab, chemotherapy, prednisone |
| Locations | 3 sites (Akron, Ohio and 2 other locations) |
| Status | Recruiting |
| Started | February 5, 2014 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT02048332 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who are at least 21 days post-allogeneic stem cell transplant and have achieved engraftment.
✕Probably not a fit
Patients with active acute graft-versus-host disease or uncontrolled infections may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of donor-derived viral specific T-cells (VSTs) to combat viral infections that may arise following allogeneic stem cell transplants. Participants who have undergone or are scheduled for such transplants will receive VST infusions if they show signs of viral infections. The T-cells are generated from the donor's blood and are specifically designed to target and eliminate virus-infected cells. Patients will be monitored closely for their response to the treatment, with the possibility of receiving multiple infusions if necessary.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of viral infections and associated complications in patients post-transplant.
How similar studies have gone: Other studies have shown promise in using T-cell therapies for viral infections post-transplant, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Active acute GVHD grades II-IV * Uncontrolled bacterial or fungal infection * Uncontrolled relapse of malignancy requiring treatment with chemotherapy * Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
Where it's running
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Akron Children's Hospital
Akron, Ohio, United States Recruiting -
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Recruiting -
University of Cincinnati Medical Center
Cincinnati, Ohio, United States Completed
Study contacts
- Principal investigator: Michael Grimley, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Jamie Wilhelm, BS
- Email: Jamie.Wilhelm@cchmc.org
- Phone: (513) 803-1102
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Infusion of donor-derived T-cells for viral infections in immunocompromised patients
This study is testing whether T-cells from donors can help children with weakened immune systems fight off viral infections like EBV, CMV, and ADV after they have had stem cell transplants.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.