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Study of VSTs for Viral Infections After Stem Cell Transplant

This study is looking at how well Viral Specific T-cells (VSTs) work to prevent or treat viral infections after an allogeneic (donor) stem cell transplant. VSTs are special cells designed to fight viruses. You might receive VSTs on a regular schedule, or only if a viral infection is detected. The researchers want to see if one approach leads to fewer treatment failures within 21 to 100 days after your transplant. This study is for people who have had a stem cell transplant and are at least 21 days post-transplant, can reduce steroid use, and are not critically ill. You cannot join if you have active acute GVHD (Graft Versus Host Disease) or uncontrolled cancer relapse. The study aims to enroll 180 participants, but its current status is unclear.

Study design
This is an interventional study comparing two ways of giving Viral Specific T-cells (VSTs) to participants after a stem cell transplant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of the study is measured between 21 and 100 days after transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04230356

Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

Recruiting
PHASE2All AgesInterventional
Children's Hospital Medical Center, Cincinnati
~180 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Viral Specific T-cells (VSTs) ScheduledViral Specific T-cells (VSTs) Treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Treatment Failures
Measured over 21 - 100 days after transplant

Conditions

Allogeneic Stell Cell Transplant
Viral Infection

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Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Stella Davies, MBBS, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Celeste Dourson, MS
[email protected]
513-636-7679
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Exclusion

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.

What this trial measures

  • Number of Treatment Failures21 - 100 days after transplant

    Treatment failure is defined as EBV\>100,000, BKV \>100,000, CMV \>5,000 or Adv \>50,000 at any time post randomization.