Study on MaaT013 for Treating Acute Gastrointestinal Graft-Versus-Host Disease in Patients Not Responding to Ruxolitinib

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What is this study about?

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.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and previous treatments for acute graft-versus-host disease (aGvHD) affecting the gastrointestinal tract.

Informed consent is required, which involves understanding the study’s purpose and agreeing to participate.

2 treatment initiation

The treatment involves the administration of MaaT013, a rectal solution containing allogeneic fecal microbiota.

The solution is administered rectally, which means it is introduced into the body through the rectum.

3 treatment duration

The primary evaluation of the treatment’s effectiveness occurs at day 28 (D28) after the start of the treatment.

Further assessments are conducted at day 56 (D56) and month 3 (M3) to evaluate the overall response rate (ORR) for gastrointestinal and other organ involvement.

4 safety and effectiveness evaluation

The study aims to evaluate the safety of MaaT013 and its effectiveness in improving symptoms of aGvHD.

The primary goal is to assess the overall response rate at day 28, with secondary evaluations at later stages.

5 follow-up assessments

Additional assessments include monitoring the duration of response, overall survival, and progression-free survival.

The study also evaluates the ability to reduce or stop corticosteroid use and measures changes in patient-reported outcomes.

Who Can Join the Study?

  • Must be 18 years old or older.
  • Must have had an Allo-HSCT, which is a type of stem cell transplant from a donor.
  • Must have an acute GvHD episode affecting the gastrointestinal (GI) tract. GvHD stands for graft-versus-host disease, a condition where the donor cells attack the patient’s body.
  • Must be resistant to steroids and either resistant to or intolerant of ruxolitinib. Steroids are medications used to reduce inflammation, and ruxolitinib is a drug used to treat GvHD.
  • Must sign an informed and written consent form, or have it signed by a legally acceptable representative if under guardianship or trusteeship.

Who Cannot Join the Study?

  • Patients who have a different type of illness that is not related to the treatment of acute graft-versus-host disease affecting the gastrointestinal tract.
  • Patients who are not resistant or intolerant to the medication called ruxolitinib.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population, which means they do not have additional health or social factors that make them more at risk.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre hospitalier universitaire de Liege Liege Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital General Universitario Morales Meseguer Murcia Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Universitaetsklinikum Mannheim GmbH Mannheim Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Ovousdtubuabzd Lxyy Gokw Linz Austria
Hhmzpnug Urwbwvbsidzfl Mlprfgz Dc Vwlowyorcb Santander Spain
Ijdhjkxu Cxgvgp Depklfsgdkbdxwtdk L'hospitalet De Llobregat Spain
Aplkvbv Olbnshkaytt Ufxgxctszqktt Cydkhvezfhzf Dstgn Srrfcw E Dxquu Sdxgsfb Dp Tpoxyw Turin Italy
Cmko Ds Norar Vandoeuvre Les Nancy France
Uctnczfwsgzmvxzrxdgeq Wlbsnoran Alt Wuerzburg Germany
Anxumpv Ugbla Sorpmebfk Lswejc Dz Bjyefiu Bologna Italy
Hfhasmtj Dv Ly Sqqqo Cqnl I Sylt Pwh Barcelona Spain
Cfgvmv Hvddkhdrqks Rodoutxm Deegtokyvnupak Angers France
Fgybdxxnr Phvf Ld Iaghktdxahmou Bhgedoriq Dco Heshofmx Uaatwdyntzqlx Lw Phy Madrid Spain
Iilosfxz dt Ckqzvozurhpc Hpymkmnaapd Udxdvqogacmpg dz Srmjs Effqvtp (wyrrmtt Saint Priest En Jarez France
Idbrudsg Pbxziluwlmhtdpw Cckqbl Cfaeel Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
22.03.2022
Belgium Belgium
Not recruiting
22.03.2022
France France
Not recruiting
22.03.2022
Germany Germany
Not recruiting
22.03.2022
Italy Italy
Not recruiting
22.03.2022
Spain Spain
Not recruiting
22.03.2022

Trial locations

MaaT013 is a therapy being evaluated for its effectiveness in treating patients with acute graft-versus-host disease (aGVHD) that affects the gastrointestinal tract. This condition occurs when donor cells attack the recipient’s body after a transplant. MaaT013 is being tested as a salvage therapy, which means it is used when other treatments, like ruxolitinib, have not worked. The goal is to see if MaaT013 can improve the condition of the gastrointestinal tract in these patients.

Acute Graft-Versus-Host Disease (aGvHD) – This condition occurs when donor immune cells attack the recipient’s body after a stem cell or bone marrow transplant. It primarily affects the skin, liver, and gastrointestinal tract. In the gastrointestinal tract, it can cause symptoms such as diarrhea, abdominal pain, and nausea. The disease progresses as the immune response intensifies, leading to increased inflammation and tissue damage. Patients may experience varying degrees of severity, with some cases resolving over time while others persist. The condition is considered rare and can be challenging to manage, especially in patients who do not respond to standard treatments like ruxolitinib.

Trial ID:
2024-513023-17-00
Protocol code:
MPOH06
NCT ID:
NCT04769895
Trial Phase:
Therapeutic confirmatory (Phase III)

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