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Haplo-identical Viral-Specific T-cells for CMV and Adenovirus Infections After Transplant

This study is looking at whether a treatment called VST infusion can safely and effectively treat cytomegalovirus (CMV) and/or adenovirus (ADV) infections in children up to 18 years old who have had a hematopoietic cell transplant (HCT). VST infusion uses special infection-fighting cells (T-cells) from a donor, prepared with a device called CliniMACS. The main goal is to see if the amount of virus in your blood significantly decreases four weeks after receiving the VST infusion. You may be able to join if you've had a haploidentical HCT or a matched-sibling/matched-unrelated donor HCT and have CMV and/or ADV that hasn't responded to standard antiviral medicines. The study plans to enroll 42 participants, but the current recruitment status is unclear.

Study design
This interventional study plans to enroll 42 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 4 weeks after VST infusion.

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NCT05664126

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

Recruiting
PHASE2Up to 18InterventionalTreatment
St. Jude Children's Research Hospital
~42 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:VST infusionCliniMACS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Degree of reduction of CMV and/or ADV viral load
Measured over 4 weeks after VST infusion

Conditions

Cytomegalovirus
Adenovirus

Explore related trials

AdenovirusCytomegalovirus

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Naik Swati, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Naik Swati, MD
[email protected]
866-278-5833
Email the study team

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Degree of reduction of CMV and/or ADV viral load4 weeks after VST infusion

    The primary objective of this clinical study is to evaluate the efficacy of adoptively transferred CMV- and ADV-specific haploidentical T-cells in patients who have undergone allogeneic HCT. This primary endpoint is defined as ≥1 log10 reduction in CMV and/or ADV viral load 4 weeks after VST infusion. When the initial viral load is \<1 log10 above the threshold of detection the endpoint will be a reduction to below the threshold of detection. The success rate will be evaluated using descriptive statistics (sample proportion and standard error). Patients with both CMV and ADC detected will count as success if reduction occurs in one or both of CMV and ADV.