Immune cells from donors may tame stubborn viruses in transplant kids
NCT ID NCT05664126
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether specially selected immune cells from a donor can safely treat cytomegalovirus (CMV) and adenovirus (ADV) infections in children who have had a stem cell transplant. About 42 participants will receive these virus-fighting cells and be monitored for viral load reduction and side effects. The goal is to control the infection without long-term medication.
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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 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Dec 2029
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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Up to 18 years
- 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 for Patients: * Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05. * Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment. * Patients have no suspected or confirmed GVHD. * Availability of haploidentical donor for isolation of virus-specific T-cells. * Have not received a Donor Lymphocyte Infusion in the past 4 weeks. * Female patients of childbearing age must have a negative pregnancy test. * Subject, parent, or guardian are capable of giving signed informed consent. * Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%. * Patients must have a bilirubin less than or equal to 2.5mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal. * Patients must have an estimated glomerular filtration rate (GFR) greater than 60mL/min/1.73m2 (may use estimated GFR that is auto calculated in the EHR). * Patients must be free of severe infection which upon determination of the principal investigator precludes therapy with VST. * Patients must have FVC \>50% predicted or able to maintain pulse oximetry saturation \> 92% on room air. * Gut diarrhea \<1 liter/day (adults) or \<20mL/kg/day (children) or if unable to quantify, then occurrence of 4 stools per day above baseline. * Patients must have engrafted with an ANC \>500 cells/mm3 for 3 consecutive days. Inclusion criteria for donors * Age ≥18 years. * At least single haplotype matched (≥3/6) family member. * Donor will be identical to the stem cell donor (Cohort A) or different from the stem cell donor (Cohort B). * HIV negative. * For females of childbearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND not lactating with intent to breastfeed. * Regarding donation eligibility, is identified as either having completed the process of donor eligibility determination as outlined in 21CFR 1271 and agency guidance or does not meet 21CFR 1271 eligibility requirements but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21CFR. * Identified recipient with CMV and/or ADV reactivation post-HCT. Exclusion Criteria for Patients: * Active GVHD. * Pregnancy. * Inability to provide consent. * Need for vasopressor or ventilatory support Patients receiving steroids \>0.5 mg/kg prednisone equivalent at the time of VST infusion * Donor Lymphocyte Infusion within 4 weeks prior to VST infusion. * Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion. * Other severe uncontrolled concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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St . Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The Little-Known virus that may rival RSV and flu in older adults
- Can specially grown immune cells from donors beat viruses that won't go away?
- Lab-Grown immune cells take aim at Life-Threatening viruses in vulnerable patients
- Experimental immune cell therapy for transplant viruses shows early promise but study halted
- Saliva swab could spot hidden virus in kids
- Donor immune cells take on tough viruses in transplant patients