NCT05017688

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

PrOspective inteRventional Study Exploring the mIcrobiota recolONization in Steroid-Refractory Graft-versus-Host Disease Patients Receiving MaaT013

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: MaaT Pharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.

Detailed description

The french regulatory authority ANSM approved in July 2019 the use of MaaT013, a pooled microbiome-based enema formulation, under a formalized named-patient use program in France called "Autorisation Temporaire d'Utilisation - ATU nominative protocolisée - ATUn" or Early Access. The ATUn is indicated to provide a benefit in the treatment of patients with grade III-IV aGVHD: * In case of initial resistance to CS alone or in association or in case of failure to other treaments * In first-line therapy in association with CS in case of steroid-dependance (inability to taper CS dose \<0.5 mg/kg/d) * In case of digestive aGvHD with overlap syndrome The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients. Blood and stool samples will be collected at each visit which explained why the study is thus categorized as research involving the human person with low risks and constraints clinical trial (RIPH2).

Conditions

• Intestinal GVHD
• Steroid Refractory GVHD

Interventions

Type	Name	Description
PROCEDURE	Blood and stool sample collection	Collection of blood samples (55 mL) Collection of fecal samples (10g)

Timeline

• Start date: 2021-10-06
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2021-08-24
• Last updated: 2023-10-11

Locations

9 sites across 1 country: France