Can donor t cells beat a tough virus after transplant? new trial aims to find out.
NCT ID NCT03378102
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether infusing virus-fighting T cells from a donor can help stem cell transplant patients overcome a stubborn adenovirus infection. About 20 participants will receive the experimental cell therapy, and researchers will monitor side effects and whether the virus clears. The goal is to see if this approach is safe and feasible.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Dec 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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3 months and older
- 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.
Inclusion Criteria: * Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration. * Patients must have evidence of documented HAdV infection/reactivation. Patients may be: * Symptomatic with any detectable viral load OR * Asymptomatic with viral load that is: \>1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens * Patients must have poor response and/or contraindication to therapy: * Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR * New, persistent and/or worsening HAdV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet. OR * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir, cidofovir or foscarnet. * Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 3. Karnofsky (≥ 16 years) or Lansky (\<16 years) performance score ≥ 50 * The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment. * Subjects who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document, or assent document. Exclusion Criteria: * Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents described above, breastfeeding should be discontinued if the mother participates in this trial. * Patients with opportunistic viral infections other than HAdV. * Patients with active, grade II-IV, acute graft versus host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\>0.5 mg/kg/day prednisone or its equivalent) as treatment. * Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells. * Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
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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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University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
RECRUITINGCleveland, Ohio, 44106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug speed recovery after stem cell transplant?
- Can a detailed health check predict who thrives after a stem cell transplant?
- Can a Life-Saving transplant leave hidden scars on a Child's mind?
- Can a Low-Dose antifungal shield vulnerable patients from deadly fungal infections?
- Could a simple drug infusion stop a dangerous virus after stem cell transplants?
- Study to reveal if younger donors boost transplant success