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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

6 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

MaaT013 – MaaT013 is administered as an enema, targeting the gastrointestinal tract directly. It is currently being evaluated in clinical trials for its effectiveness in treating acute graft-versus-host disease (aGvHD) in patients who do not respond to or cannot tolerate ruxolitinib. The main therapeutic indication is for gastrointestinal involvement in aGvHD. MaaT013 works by restoring the balance of gut microbiota, which is believed to help modulate the immune response and reduce inflammation. It is classified as a microbiome therapeutic, focusing on the use of live biotherapeutic products to treat disease.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513023-17-00Protocol codeMPOH06Estimated enrolment73 patientsSponsorMaat Pharma

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