This clinical trial is focused on studying a condition known as acute graft-versus-host disease (aGVHD), which affects the gastrointestinal (GI) tract. This condition can occur in patients who have undergone a stem cell transplant and involves the donor cells attacking the patient’s body. The trial is specifically for patients whose aGVHD is resistant or intolerant to a medication called ruxolitinib. The treatment being tested in this study is called MaaT013, which is a rectal solution containing a mixture of healthy bacteria from donor stool, known as allogeneic faecal microbiota.
The purpose of the study is to evaluate how effective MaaT013 is in treating aGVHD in the GI tract. Participants in the study will receive the treatment over a period of 28 days. The study will monitor the response of the disease to the treatment at various points, including day 28, day 56, and three months after starting the treatment. The study will also look at the safety of MaaT013 and how it affects the overall health and survival of the participants.
Throughout the study, researchers will assess how well the treatment works in reducing the symptoms of aGVHD and improving the patients’ quality of life. The study will also track the duration of the response to the treatment and any changes in the patients’ condition over time. The goal is to find out if MaaT013 can be a successful treatment option for patients with aGVHD who have not responded well to other treatments.



Austria
Belgium
France
Germany
Italy
Spain