Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation
Trial Parameters
Brief Summary
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
Inclusion Criteria for Patients: * 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. * Have not received a Donor Lymphocyte Infusion in the past 4 weeks. * Female patients of childbearing age must have a negative pregnancy test. * Subject, parent, or guardian are capable of giving signed informed consent. * Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%. * Patients must have a bilirubin less than or equal to 2.5mg/dL and alanine aminotransferase (ALT)