Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction

{ "Emapalumab for Acute Lung Allograft Dysfunction After Lung Transplant", "This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD). ALAD is a serious condition that can happen after a lung transplant. You may be able to join if you had a lung transplant more than 10 months ago, are at least 18 years old, and your lung function has dropped by 10% or more. Eligibility also requires elevated levels of specific markers (AI2 and CXCL9) in your lungs. The main goal is to see if your lung function improves and returns close to your usual level within 90 days after receiving a one-time infusion of emapalumab or a placebo (inactive drug). The study is currently recruiting about 40 participants.", "design": "This interventional study is testing emapalumab against a placebo. It aims to enroll 40 participants, with an initial phase to find the right dose.", "commitments": "You will undergo a bronchoscopy to collect samples for eligibility. If eligible, you will receive a one-time infusion and have your progress monitored weekly for about 4 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your lung function will be monitored to see if it returns to your baseline level within 90 days after treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07538336

Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, San Francisco
~40 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:EmapalumabPlacebo

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days
Measured over 90 days
Lung Transplant
2 sites across 1 states
California2
  • John Greenland, Dr. · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
  • John Belperio, Dr. · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

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Eligibility criteria

Inclusion

Recipients ≥10 months post-lung transplant who are enrolled in existing biorepository study (IRB #13-10738) will be approached if they have ALAD and elevated AI2 and CXCL9 levels
Age: ≥18 years old
Informed Consent: Ability to provide written informed consent to participate in the study.

Exclusion

Active CMV or EBV Infection: Active reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) based on plasma PCR testing.
Severe Comorbidities: Presence of severe conditions likely to compromise study participation or outcomes (e.g., terminal illness).
Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding at the time of screening.
Concurrent Immunosuppressive Therapy Trials: Use of investigational agents or therapies other than standard of care post-transplant immunosuppression.
Allergy to Study Drug: Known hypersensitivity to emapalumab or any of its components.
Insufficient Baseline Data: Lack of prior baseline FEV1 data for comparison.
  • Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days90 days