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Donor-Derived Viral Specific T-cells (VSTs) for Viral Infections After Stem Cell Transplant

This study is looking at a treatment called Viral specific VST Infusion (VSTs) for people who get viral infections after an allogeneic stem cell transplant (a transplant using stem cells from another person). VSTs are special white blood cells from the stem cell donor that are trained in the lab to fight viruses. Researchers want to see if these VSTs can help treat common viral infections like adenovirus, CMV, EBV, BKV, and JC Virus that can cause serious problems after a transplant. You might be able to join if you are at least 21 days past your transplant, can reduce steroid use, and have good blood counts. The study aims to see if VSTs can be made successfully, if they cause side effects within 30 minutes of infusion, and if they lead to graft-versus-host disease (GVHD) within 30 days.

Study design
This is an interventional study planning to enroll 750 participants. It is not specified if it is randomized or blinded.
What's involved
If you have signs of a virus, you will receive VST infusions, possibly up to 5 times, with at least 14-21 days between treatments. You will have daily physical exams while in the hospital and weekly exams and blood tests for 30 days after your last infusion.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored with physical exams and blood tests for 30 days after the last infusion of cells.

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NCT02048332

Donor-Derived Viral Specific T-cells (VSTs)

Recruiting
PHASE1Ages 4+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
2 of 3 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

Allogeneic Stem Cell Transplant
Viral Infection
Viral Reactivation

Explore related trials

AdenovirusBK VirusCytomegalovirusEpstein-Barr VirusViral Infection

Where it's being run

3 sites across 1 states
Ohio3

Study leadership

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

Who to contact

Jamie Wilhelm, BS
[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

Recipient 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
Recipient must have achieved engraftment with ANC ≥ 500

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

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