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

Who can join

Ages 7 and older · All sexes

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

About the study

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.

Sponsor: Brian Keller · Participants: 25 · Started: Mar 25, 2026

Contact the study team

• Brian C Keller, MD, PhD · Phone: 617-726-2147
• Mamary Kone, MD, MPH · Phone: 617-726-1082

Official record on ClinicalTrials.gov — NCT07434869

Locations in the U.S.

Conditions

• Psychology Rejection
• Bronchiolitis Obliterans
• Bronchiolitis Obliterans Syndrome

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.