Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013

Launched by MAAT PHARMA · Aug 17, 2021

Keywords

ClinConnect Summary

The ORION study is a clinical trial aimed at understanding how a treatment called MaaT013 affects the gut bacteria in patients with a serious condition known as gut graft-versus-host disease (GVHD), particularly those who have not responded to steroid treatments. The research will look at how the composition of gut bacteria changes after patients receive this treatment and how those changes may influence the immune system, which helps our bodies fight infections and diseases.

To be part of this study, participants need to be at least 18 years old and diagnosed with Grade III-IV acute GVHD that affects the gut. They must also be receiving MaaT013 through a special early access program. Importantly, individuals who are pregnant, breastfeeding, or unable to provide informed consent due to certain circumstances cannot participate. Those who join the trial can expect to undergo regular monitoring and assessments to see how their condition and gut health respond to the treatment. This study is currently seeking new participants, and it’s an opportunity to contribute to research that may help improve care for patients with similar health challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥18 years old with Grade III-IV aGVHD with gut involvement undergoing treatment with MaaT013 through named-patient use program ATUn / Early Access
• • Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship.
• • Affiliated or recipient from a social security scheme
• Exclusion Criteria:
• • Pregnancy and breastfeeding
• • Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.