Recruiting

ECP

Sponsor:

Brian Keller

Code:

NCT07434869

Conditions

Lung Transplant Failure and Rejection

CLAD, Bronchiolitis Obliterans

Extracorporeal Photopheresis

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Study Details

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

Lung Transplant Failure and Rejection

CLAD, Bronchiolitis Obliterans

Extracorporeal Photopheresis

Study ID

NCT07434869

Start date

Mar 25, 2026

Status verified date

Jul, 2026

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Lung Transplant Recipients with chronic rejection

Primary outcome measure

  • Change in Donor-Derived Cell-Free DNA (dd-cfDNA) Levels [ Time Frame: Baseline to 6 months. ]
  • Change in Lung Microvascular Measurement (MRI) [ Time Frame: Baseline to within 4 weeks after last ECP treatment ]

Central Contacts and Locations

Central contacts

Brian C Keller, MD, PhD

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

Mamary Kone, MD, MPH

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Brian C Keller, MD, PhD

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

Mamary Kone, MD, MPH

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

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Selvin Jacob, MD

617-732-7420sjacob7@bwh.harvard.edu

More Information

Sponsor

Brian Keller

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brian Keller on 2026-07-14.