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NCT Number: NCT02532452

Third Party Viral Specific T-cells (VSTs)

The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.

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Key information

Conditions

Viral Infection Adenoviridae Infections DNA Virus Infections Epstein-Barr Virus Infections Herpesviridae Infections Infection in an Immunocompromised Host Infections Tumor Virus Infections Viral Reactivation Virus Diseases

Age range

2 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Akron Children's Hospital, Akron, Ohio, United States

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About this study

Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Viral Specific VST Infusion

Biological

VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following:

  • Blood adenovirus PCR ≥ 1,000
  • Blood CMV PCR ≥ 500
  • Blood EBV PCR ≥ 9,000
  • Plasma BKV PCR >1,000
  • Plasma JC Virus PCR > 1,000
  • Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites
  • Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis
  • Evidence of invasive EBV disease/infection, 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, or EBV-associated malignancies
  • Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy
  • Evidence of PML or other CNS infection due to JC virus

Primary outcomes

  1. Successful production of viral specific T-cells

    Time frame: Within 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.

  2. Percentage of patients who do not have infusional toxicity

    Time frame: Through 30 minutes post infusion

    Patients will be monitored for infusional toxicity

  3. Incidence of GVHD associated with VST infusion

    Time frame: Through 30 days after infusion

    Patients will be monitored for the development of VST associated GVHD

Secondary outcomes

  1. Presence of viral-specific T-cells

    Time frame: At 30 days after infusion

    Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay

  2. Viral burden

    Time frame: At 30 days after infusion

    The viral burden will be assessed using the protocol-defined efficacy assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie Wilhelm

CONTACT

[email protected]

(513) 803-1102

Michael Grimley, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2015
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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