drugset / Trial / NCT05589844

A Cytomegalovirus-Directed Vaccine (CMV-alphaDC1) for Preventing Cytomegalovirus Infection or Reactivation in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

NCT05589844 ↗

Phase 1 Withdrawn Roswell Park Cancer Institute
NaSingle-groupOpen-labelPrevention

Summary

This phase Ib trial evaluates the safety and most effective dose of a cytomegalovirus (CMV) pp65 peptide-loaded alpha-type-1 polarized dendritic cell (CMV-alphaDC1) vaccination in patients who are undergoing an allogeneic hematopoietic stem cell transplant. CMV is an opportunistic infection that can occur or reactivate after allogeneic hematopoietic stem cell transplant as a result of immunosuppression. The CMV-alphaDC1 vaccine is made of white blood cells that have been exposed to molecules called cytokines, as well as CMV proteins. Introducing these dendritic cells to the patients immune system may activate an immune response to CMV, protecting against infection or reactivation.

Timeline

Start
2023-03
Primary completion
2024-11-16
Completion
2025-11-16

Outcome

Outcome not reported

Stopped: “Study never approved”

Drugs

EvaluationDrugModalityDoseRoute
Subject CMV-alphaDC1 Vaccine — Other