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

April 15, 2026 updated by: University of California, San Francisco

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 and can lead to worsening breathing and other complications. Right now, there is no approved treatment for ALAD.

The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

You may be able to join if:

You had a lung transplant more than 10 months ago, and Your lung function has dropped by 10% or more compared to your best level in the past 6 months.

What will happen in the study?

As part of your usual care, you will have a procedure called a bronchoscopy (a test that looks inside your lungs). During this test, doctors will collect samples to check for infection and measure certain markers in your lungs and blood.

These results will help determine if you can join the study.

People with certain lung infections will not be able to participate.

Study treatment

The study has two parts:

Part 1 (finding the right dose):

Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs.

Part 2 (testing how well it works):

Participants will receive the selected dose of emapalumab. Doctors will:

Monitor blood and lung markers, Check for viruses, Follow your progress weekly for about 4 weeks.

Study goals:

The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.

The study will also look at:

Whether the condition gets worse or improves, How safe the treatment is, Overall outcomes after treatment.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • Active Bacterial Infection: Positive bacterial cultures from bronchoalveolar lavage (BAL) samples at the time of ALAD diagnosis. Viral infections, which are typically treated in lung transplant recipients with a steroid taper and cleared by type I interferons, are not exclusion criteria per se.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Part I (finding the right dose)
Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs.
Drug: Emapalumab
This is a one-time infusion
Other: Part 2 (testing how well it works)

Participants will receive the selected dose of emapalumab or placebo. Doctors will:

Monitor blood and lung markers Check for viruses Follow your progress weekly for about 4 weeks
Drug: Emapalumab
This is a one-time infusion
Drug: Placebo
This is a one-time infusion of inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
CXCL9 area under the curve (AUC), safety outcomes and retransplant-free survival will be used to measure ALAD Progression
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: John Greenland, Dr., University of California, San Francisco
  • Principal Investigator: John Belperio, Dr., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 2, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-45438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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