Recruiting
Phase 2

CMV Immunity

Sponsor:

NYU Langone Health

Code:

NCT05708755

Conditions

Lung Transplant; Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)

Donor-Derived Cell-Free DNA (dd-cfDNA) Assay

Valganciclovir

Study Details

Brief 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

Study ID

NCT05708755

Start date

Sep 13, 2024

Status verified date

May, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
2. Pre-existing serological immunity to CMV (R+)
3. Able and willing to provide informed consent

Exclusion Criteria:

1. Anti-thymocyte globulin induction immunosuppression
2. Perioperative desensitization
3. Pregnant or breastfeeding women

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lung Transplant Recipients

Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.

Interventions

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).

Donor-Derived Cell-Free DNA (dd-cfDNA) Assay

Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.

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.

Primary outcome measure

  • CMV Viremia-Free Survival [ Time Frame: Up to Month 12 Post-Transplant ]

Central Contacts and Locations

Central contacts

Tyler Lewis

866-838-5864Tyler.lewis@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Tyler Lewis

866-838-5864Tyler.lewis@nyulangone.org

More Information

Sponsor

NYU Langone Health

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-29.