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.
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.
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
Sequential
VST infusion
Drugsingle intravenous (IV) infusion.
CliniMACS
DeviceCells infusions are prepared using the ClinMACS
Degree of reduction of CMV and/or ADV viral load
The primary objective of this clinical study is to evaluate the efficacy of adoptively transferred CMV- and ADV-specific haploidentical T-cells in patients who have undergone allogeneic HCT. This primary endpoint is defined as ≥1 log10 reduction in CMV and/or ADV viral load 4 weeks after VST infusion. When the initial viral load is \<1 log10 above the threshold of detection the endpoint will be a reduction to below the threshold of detection. The success rate will be evaluated using descriptive statistics (sample proportion and standard error). Patients with both CMV and ADC detected will count as success if reduction occurs in one or both of CMV and ADV.
Incidence of infusion-related grade 3-5 adverse events 24 hours after infusion
The incidence of infusion-related grade 3-5 adverse events will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Incidence of AEs related to grade 3-4 cytokine release syndrome (CRS), or grade 1-2 CRS persist beyond 72 hours despite therapy
The incidence of AEs related to grade 3-4 cytokine release syndrome (CRS), or grade 1-2 CRS persist beyond 72 hours despite therapy will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Incidence of Grade 3-4 Neurotoxicity of any duration
The incidence of Grade 3-4 Neurotoxicity of any duration will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Incidence of Grade 3-4 GVHD
The incidence of Grade 3-4 GVHD will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
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