NCT05708755

CMV Immunity Monitoring in Lung Transplant Recipients

Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.

Conditions

• Lung Transplant; Complications

Interventions

Type	Name	Description
DEVICE	Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)	Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).
DIAGNOSTIC_TEST	Donor-Derived Cell-Free DNA (dd-cfDNA) Assay	Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.
DRUG	Valganciclovir	Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and/or adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2023-02-01
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study