drugset / Trial / NCT03798301

Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells

NCT03798301

Phase 1 Terminated 3 enrolled University of Wisconsin, Madison
NaSingle-groupOpen-labelTreatment

Summary

The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections. The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy). Participants will be followed for one year.

Timeline

Start
2020-02-06
Primary completion
2023-05-31
Completion
2023-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CMV-specific T-cells Cell therapy 25000 cells/kg Intravenous