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Third Party Viral Specific T-cells (VSTs) for Viral Infections

This study is looking at a treatment called Viral Specific VST Infusion (a type of white blood cell therapy) for immunocompromised patients who have viral infections or reactivations. These infections can be caused by viruses like Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), or JC Virus. The VSTs are taken from healthy, unrelated donors and then given to patients. The goal is to see if these VSTs can be successfully made and given safely without causing serious side effects like graft-versus-host disease (GVHD). You could be eligible if you are immunocompromised, have one of these viral infections, and are at least 2 days old. The study is planning to enroll 750 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a treatment. It aims to enroll 750 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for 30 minutes after infusion and for 30 days after infusion.

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

NCT02532452

Third Party Viral Specific T-cells (VSTs)

Recruiting
PHASE2Ages 2+InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~750 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Viral Specific VST Infusion

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful production of viral specific T-cells
Measured over Within 30 days post culture initiation
+2 more outcomes measured

Conditions

Viral Infection
Viral Reactivation
Infection in an Immunocompromised Host

Explore related trials

Adenovirus InfectionBK Virus InfectionCytomegaloviral InfectionEBV InfectionViral Infection

Where it's being run

4 sites across 1 states
Ohio4

Study leadership

  • Michael Grimley, MD, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Jamie Wilhelm
[email protected]
(513) 803-1102
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Immunocompromised patient with evidence of viral infection or reactivation
Age \>1 day
Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent
Must be able to receive CTL infusion in Cincinnati
Informed consent obtained by PI or sub-investigator either in person or by phone

Exclusion

Active acute GVHD grades II-IV
Uncontrolled bacterial or fungal infection
Uncontrolled relapse of malignancy requiring treatment with chemotherapy
Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days

What this trial measures

  • Successful production of viral specific T-cellsWithin 30 days post culture initiation

    Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.

  • Percentage of patients who do not have infusional toxicityThrough 30 minutes post infusion

    Patients will be monitored for infusional toxicity

  • Incidence of GVHD associated with VST infusionThrough 30 days after infusion

    Patients will be monitored for the development of VST associated GVHD