Lung Transplant; ComplicationsPhase 2NCT05708755
CMV Immunity Monitoring in Lung Transplant Recipients
A Phase 2 study testing Cytomegalovirus T Cell Immunity Panel (CMV-TCIP), Donor-Derived Cell-Free DNA (dd-cfDNA) Assay and Valganciclovir in people with Lung Transplant; Complications, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Cytomegalovirus T Cell Immunity Panel (CMV-TCIP), Donor-Derived Cell-Free DNA (dd-cfDNA) Assay and Valganciclovir
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
- Pre-existing serological immunity to CMV (R+)
- Able and willing to provide informed consent
Who cannot join
- Anti-thymocyte globulin induction immunosuppression
- Perioperative desensitization
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Tyler Lewis, 866-838-5864, Tyler.lewis@nyulangone.org
About this study
Official title: Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
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
- Being tested
- Cytomegalovirus T Cell Immunity Panel (CMV-TCIP), Donor-Derived Cell-Free DNA (dd-cfDNA) Assay, Valganciclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)Device
Also called Viracor inSIGHT
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) AssayDiagnostic test
Also called Viracor TRAC
Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.
ValganciclovirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung Transplant Recipients | Experimental | 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. Receives: Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP); Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay; Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV Viremia-Free Survival
Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.
Measured: Up to Month 12 Post-Transplant
Secondary outcomes (7)
Incidence of CMV Viremia
Number of times CMV DNA is detected in patients' blood.
Measured: Up to Month 12 Post-Transplant
Incidence of CMV Viremia Requiring Treatment
Number of times treatment is necessary after CMV DNA is detected in patients' blood.
Measured: Up to Month 12 Post-Transplant
Incidence of Treatment-Resistant CMV Viremia
Number of times treatment for CMV Viremia does not appear effective after CMV DNA is detected in patients' blood.
Measured: Up to Month 12 Post-Transplant
Incidence of Bacterial Pneumonia
Measure of non-CMV post-transplant infectious complications.
Measured: Up to Month 12 Post-Transplant
Incidence of Aspergillus Infection
Measure of non-CMV post-transplant infectious complications.
Measured: Up to Month 12 Post-Transplant
Incidence of Varicella Zoster Reactivation
Measure of non-CMV post-transplant infectious complications.
Measured: Up to Month 12 Post-Transplant
Incidence of Neutropenia
Measured: Up to Month 12 Post-Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start13 Sep 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Viracor Eurofins
- Responsible party
- Sponsor
- Investigators
- Luis Angel, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708755
- Sponsor's protocol ID
- 22-01138
- Status last verified
- May 2026
- First submitted
- 24 Jan 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT05708755
- Acronym / sponsor ID
- 22-01138
- Conditions
- Lung Transplant; Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Viracor Eurofins
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Transplant Recipients | Experimental | Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP), Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay, Drug: ValganciclovirLung 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
- Pre-existing serological immunity to CMV (R+)
- Able and willing to provide informed consent
Key exclusion criteria (3 listed)
- Anti-thymocyte globulin induction immunosuppression
- Perioperative desensitization
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)Also: Viracor inSIGHTWhole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS). | Device | Lung Transplant Recipients |
| Donor-Derived Cell-Free DNA (dd-cfDNA) AssayAlso: Viracor TRACDetermines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts. | Diagnostic test | Lung Transplant Recipients |
| ValganciclovirDelivered 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. | Drug | Lung Transplant Recipients |
Primary outcome
CMV Viremia-Free Survival
Time frame: Up to Month 12 Post-Transplant
Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.
7 secondary outcomes
Incidence of CMV Viremia
Time frame: Up to Month 12 Post-Transplant
Incidence of CMV Viremia Requiring Treatment
Time frame: Up to Month 12 Post-Transplant
Incidence of Treatment-Resistant CMV Viremia
Time frame: Up to Month 12 Post-Transplant
Incidence of Bacterial Pneumonia
Time frame: Up to Month 12 Post-Transplant
Incidence of Aspergillus Infection
Time frame: Up to Month 12 Post-Transplant
Incidence of Varicella Zoster Reactivation
Time frame: Up to Month 12 Post-Transplant
Incidence of Neutropenia
Time frame: Up to Month 12 Post-Transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis Angel, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytomegalovirus T Cell Immunity Panel (CMV-TCIP), Donor-Derived Cell-Free DNA (dd-cfDNA) Assay and Valganciclovir in people with Lung Transplant; Complications, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tyler Lewis (866-838-5864, Tyler.lewis@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV Viremia-Free Survival (time frame: Up to Month 12 Post-Transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.