Biomarkers for Response to ECP in Lung Transplant Patients with CLAD
Official title: Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD
Run by Massachusetts General Hospital · NCT07434869 · Data updated 2026-11-12
This study tests early biomarkers from blood and MRI to see if extracorporeal photopheresis helps lung transplant patients with chronic lung allograft dysfunction.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | alemtuzumab |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Status | Recruiting |
| Started | March 25, 2026 |
| Main results expected | February 28, 2030 |
| Study ends | February 28, 2030 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07434869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults or children 7 years and older with a lung transplant who have CLAD and are prescribed ECP.
✕Probably not a fit
Patients who do not show biomarker changes associated with response or have MRI contraindications may not benefit from the biomarkers being studied.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects blood samples at three time points during a 6-month extracorporeal photopheresis course prescribed by a patient’s physician. Some participants will have two lung MRI scans with contrast to visualize blood flow and tissue changes, aiding biomarker discovery. Investigators will analyze immune cells in blood and cell-free DNA to identify signals associated with treatment response. The study does not change the standard ECP regimen or introduce a new drug, but seeks early indicators of benefit to guide care. It involves adult and pediatric lung transplant recipients with CLAD treated at participating centers in Boston and Columbus.
Why it matters
Potential benefit: If successful, biomarkers could help clinicians determine early whether ECP is helping a patient with CLAD, allowing faster treatment decisions.
How similar studies have gone: Previous research in related settings has identified potential biomarkers for transplant responses, but this specific ECP-CLAD biomarker study is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Brian C Keller, MD, PhD — Massachusetts General Hospital
- Study coordinator: Brian C Keller, MD, PhD
- Email: bckeller@mgh.harvard.edu
- Phone: 617-726-2147
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.