A Phase 2 interventional study of Viral Specific VST Infusion in Viral Infection, Viral Reactivation and Infection in an Immunocompromised Host, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 4 sites in United States. Open to participants aged 2 Days and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
3rd party VST infusion
Biological: Viral Specific VST Infusion
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
Successful production of viral specific T-cells
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Time frame: Within 30 days post culture initiation
Percentage of patients who do not have infusional toxicity
Patients will be monitored for infusional toxicity
Time frame: Through 30 minutes post infusion
Incidence of GVHD associated with VST infusion
Patients will be monitored for the development of VST associated GVHD
Time frame: Through 30 days after infusion
Presence of viral-specific T-cells
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Time frame: At 30 days after infusion
Viral burden
The viral burden will be assessed using the protocol-defined efficacy assessment.
Time frame: At 30 days after infusion
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Children's Hospital Medical Center, Cincinnati