Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD

NCT07434869 | Recruiting

• 1 other identifier: 2024P002968
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

This study is for people who have had a lung transplant and developed a condition called chronic lung allograft dysfunction (CLAD), which is a type of chronic rejection. Doctors often treat CLAD with a procedure called extracorporeal photopheresis (ECP), but it can take up to six months to know if the treatment is working. The goal of the study is to find early signs (biomarkers) that show whether ECP is helping, so patients can get the right care sooner. For participants in the study, small blood samples will be collected at three points during ECP treatment and, for some participants, two MRI scans of the lungs will be performed-one before starting ECP and one after finishing treatment. The MRI uses a safe contrast dye to help us see changes in lung blood flow and tissue. Investigators will also look at certain immune cells in the blood. This is not a study of a new drug or treatment-participants will receive the same ECP therapy their doctor already recommended. The study will help researchers understand how ECP works and identify markers that predict who benefits most. There is no direct benefit to participants, but participation may help improve care for future lung transplant patients.

Conditions

CLAD, Bronchiolitis Obliterans; Extracorporeal Photopheresis; Lung Transplant Failure and Rejection

Keywords

Chronic Lung Allograft Dysfunction (CLAD); Chronic Lung Rejection; Bronchiolitis Obliterans Syndrome (BOS); Lung Transplant Recipients; Restrictive Allograft Syndrome (RAS)

Outcome Measures

Primary Outcomes (2)

• Change in Donor-Derived Cell-Free DNA (dd-cfDNA) Levels

  Measure changes in dd-cfDNA levels from baseline at three time points (before ECP #1, #15, and #24).

  Baseline to 6 months.

• Change in Lung Microvascular Measurement (MRI)

  Change from baseline in peak enhancement on dynamic contrast-enhanced MRI after ECP treatment.

  Baseline to within 4 weeks after last ECP treatment

Study Arms (1)

Lung Transplant Recipients with chronic rejection

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone lung transplantation, developed CLAD and been prescribed ECP therapy in addition to standard of care immunosuppression by their transplant clinician.

You may qualify if:

• Adults (≥18 years) or pediatric patients (7-17 years) who have had a single or double lung transplant
• Diagnosed with CLAD (any stage) and prescribed ECP therapy
• Ability to provide informed consent (or assent with parental consent for minors)

You may not qualify if:

• Previously received ECP treatment
• Receipt of anti-thymocyte globulin within 3 months or alemtuzumab within 12 months of ECP initiation
• Contraindications to MRI (for MRI subgroup), including metal implants, claustrophobia, seizure disorder
• Known allergy to gadolinium or impaired kidney function (eGFR \<30 ml/min)
• Pregnant or breastfeeding

Sponsors & Collaborators

• Brian Keller: lead
• Therakos: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Rejection, Psychology; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Organizing Pneumonia; Graft vs Host Disease; Immune System Diseases

Study Officials

• Brian C Keller, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian C Keller, MD, PhD

CONTACT

617-726-2147; bckeller@mgh.harvard.edu

Mamary Kone, MD, MPH

CONTACT

617-726-1082; mkone@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

US (3)