About this trial
The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection.
Primary objective
To determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and/or ADV viral load in the peripheral blood 4 weeks after VST infusion.
When the initial viral load is \<1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection.
Secondary objectives
* Determine the safety of VSTs when used to treat CMV and/or ADV viremia post-HCT. * Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion. * Assess the persistence of response for 6 months post-infusion.
Eligibility criteria
Qualifiers
Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05.
Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.
Patients have no suspected or confirmed GVHD.
Availability of haploidentical donor for isolation of virus-specific T-cells.
Disqualifiers
Active GVHD.
Pregnancy.
Inability to provide consent.
Need for vasopressor or ventilatory support Patients receiving steroids >0.5 mg/kg prednisone equivalent at the time of VST infusion
Trial design
Treatments tested in this trial
- VST infusion
- CliniMACS