Can donor cells stop viruses after transplant?
NCT ID NCT04230356
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether giving patients donor-derived immune cells (VSTs) on a regular schedule can prevent dangerous viral infections after a stem cell transplant. 180 participants will be randomly assigned to receive VSTs either on a fixed schedule or only when a virus is detected. The goal is to see if scheduled dosing reduces treatment failures and the need for harsh antiviral medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor-derived viral specific T-cells (VSTs)
- What this could lead to
- If successful, this approach could reduce severe viral infections after stem cell transplant and limit the need for toxic antiviral drugs.
- What could go wrong
- This is a Phase 2 trial with 180 participants, so results are still early. The treatment may not work for all viruses or could cause side effects like graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
SCHEDULED ARM: Inclusion Criteria: * Recipient must be at least 21 days after stem cell infusion * Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent * No critical illness making VST infusion hazardous Exclusion Criteria: * Active acute GVHD grades II-IV. * Uncontrolled relapse of malignancy. * Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point. TREATMENT ARM Inclusion Criteria: * Blood adenovirus PCR ≥1,000 * Blood CMV PCR ≥ 500 * Blood EBV PCR ≥ 9,000 * Plasma BKV PCR \>1,000 * Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx. * Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis * Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation. * Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy. * No active acute GVHD grades II-IV * No uncontrolled relapse of malignancy * No infusion of ATG or alemtuzumab within 2 weeks of VST infusion. * Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
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Other studies related to the condition(s) this trial covers.
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- Immune cell therapy shows promise for BK virus in transplant kids