A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

To be part of this study, you need to be at least 12 years old and have been recently diagnosed with moderate or severe chronic graft-versus-host disease (cGVHD) that needs a general treatment for your whole body (not just one area). You must have had one stem cell transplant in the past. Your blood counts also need to be at a certain healthy level.

There are several reasons why you might not be able to join. For example, if you've had more than one stem cell transplant, or if you've already received treatment specifically for your cGVHD (like steroids or a special blood filtering treatment). You also can't have certain other health problems like a recent blood clot, active muscle inflammation, or severe kidney problems. If you've recently taken certain medications, like particular types of immune-suppressing drugs or another drug called a JAK inhibitor, you might also not be able to participate, unless you met specific conditions.

If you decide to participate, you'll be given the study medications, axatilimab and ruxolitinib, over a period of time. You'll have regular hospital visits for check-ups, blood tests, and other assessments to monitor your health and how well the treatment is working. The study team will guide you through all the necessary steps and appointments. The total duration of your participation will depend on the study design and your response to treatment, including follow-up care after you stop taking the study drugs. You'll receive detailed information about the schedule of visits and procedures if you are considering joining.