Study of Emapalumab to Prevent Graft Rejection in Patients Receiving Hematopoietic Stem Cell Transplant

What this Trial Is About

Researchers are investigating whether blocking interferon gamma with emapalumab can prevent graft rejection in patients receiving hematopoietic stem cell transplants HSCT. This study focuses on high-risk patients, as graft rejection is a serious complication that currently can only be treated by re-transplantation, which carries higher risks. The trial also aims to understand how emapalumab behaves in the body to help improve dosing and treatment approaches in future research. Participants are randomly assigned to receive one of two intravenous doses of emapalumab 3 mgkg or 10 mgkg on the day after their transplant. If signs of acute graft rejection appear, up to two additional rescue doses of 10 mgkg may be given, with timing determined by the lead investigator. Because emapalumab binds to circulating interferon gamma, the drug may be consumed quickly, so rescue doses can be administered as soon as 24 hours after the prior dose. During the study, participants will be closely monitored through blood tests measuring drug levels, markers like CXCL9, and immune responses up to 42 days after dosing or rescue treatment. The primary outcome is to assess the preliminary effectiveness of emapalumab over the first 100 days post-transplant. Researchers will also track survival, infections, and graft function. The total study duration extends to 100 days after HSCT to evaluate safety and outcomes.

Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients