Emapalumab for Lung Transplant Complications

(TIGER-Lung Trial)

This trial tests a medication called emapalumab, an immunotherapy, to assist individuals who have undergone a lung transplant and are experiencing acute lung allograft dysfunction (ALAD). ALAD can significantly worsen breathing, and no approved treatments currently exist. The trial aims to determine if emapalumab can restore lung function to usual levels within 90 days. Suitable candidates include those who had a lung transplant over 10 months ago and are now experiencing declining lung function. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential breakthroughs in ALAD treatment.

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are in another trial for immunosuppressive therapy.

Research has shown that emapalumab has been used in other conditions with promising results. For example, it has been administered to patients with severe immune system problems and has generally proven safe and effective. However, one case involved a child with severe Still's disease who developed acute respiratory distress syndrome (ARDS) after receiving emapalumab. This indicates that while the treatment is usually well-tolerated, risks can occur.

Emapalumab is unique because it targets and blocks a specific protein called interferon-gamma, which is involved in inflammation. Unlike other treatments for lung transplant complications, which might focus on general immune suppression, emapalumab works by specifically reducing harmful inflammation in the lungs. Researchers are excited about this treatment because it could offer a more targeted approach, potentially reducing side effects associated with broader immune suppression and improving outcomes for lung transplant patients.

Research has shown that emapalumab, a monoclonal antibody, may reduce harmful inflammation by targeting a protein called interferon-γ. This is particularly beneficial for inflammatory conditions. Studies indicate that over 60% of patients with similar diseases responded positively to this treatment. Emapalumab has also aided patients with severe lung problems from other conditions. By blocking this protein, it might stabilize lung function and reduce complications. The trial will first determine the optimal dose of emapalumab to block harmful lung inflammation. Then, it will compare the effectiveness of the selected dose to a placebo. Although no approved treatment exists for acute lung allograft dysfunction (ALAD) yet, these findings suggest emapalumab could potentially benefit individuals with this condition after a lung transplant.¹²³⁴⁶