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Study on MaaT033 to Prevent Complications in Patients with Blood Cancer Undergoing Stem Cell Transplantation

Fast replyInvestigationalNo 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 patients with hematologic malignancies, which are types of blood cancers. These patients are undergoing a procedure called allogeneic hematopoietic cell transplantation (alloHCT), a treatment that involves replacing diseased bone marrow with healthy cells from a donor. The study is testing a new treatment called MaaT033, which is an oral medication in the form of a prolonged-release capsule. MaaT033 contains a special mixture known as allogeneic fecal microbiota, which is designed to help prevent complications that can occur after the transplantation.

The purpose of the study is to compare the effectiveness of MaaT033 with a placebo in improving overall survival rates at 12 months after the treatment begins. Participants in the study will be randomly assigned to receive either MaaT033 or a placebo, which is a capsule that looks like the treatment but does not contain the active substance. The study is conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results.

Throughout the study, participants will take the medication orally, and their health will be monitored over a period of time to assess the treatment's impact on their survival and any potential side effects. The study aims to provide valuable information on whether MaaT033 can effectively prevent complications in patients undergoing alloHCT, potentially leading to better outcomes for those with blood cancers.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be randomly assigned to receive either the MaaT033 treatment or a placebo. The placebo is a capsule that looks like the treatment but does not contain the active substance.

  2. Step 2

    Medication administration

    You will take the assigned capsule orally. The capsule is a prolonged-release form, which means it releases the substance slowly over time.

    The dosage, frequency, and duration of administration will be provided by the medical team overseeing the trial.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular check-ups and assessments to track your overall health and any changes that may occur.

    The main goal is to evaluate the effectiveness of the treatment in preventing complications related to your condition.

  4. Step 4

    Completion of the trial

    The trial aims to assess the overall survival rate at 12 months after you start the treatment. This means your progress will be followed for at least one year.

    At the end of the trial, the results will be analyzed to determine the success of the treatment compared to the placebo.

Who can join the trial?

7 criteria

  • Patients must be 50 years or older.
  • Must have a hematologic malignancy (a type of blood cancer) for which a specific type of transplant called alloHCT is needed. This transplant should use a treatment plan that is less intense or has reduced side effects.
  • Patients must have polynuclear neutrophils (a type of white blood cell) greater than 0.5 G/L.
  • Must have taken wide spectrum antibiotics (medications that treat a variety of infections) within the last 90 days before joining the study.
  • Must have a Karnofsky index of 70% or higher. This is a score that measures a patient's ability to perform everyday activities.
  • Must have a suitable donor available, which can be a sibling, an unrelated stem-cell donor, or a familial haploidentical donor (a partially matched family member).
  • Must provide written informed consent, meaning they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

2 criteria

  • Patients who are not undergoing **allogenic hematopoietic cell transplantation**. This is a type of procedure where a patient receives blood-forming stem cells from a donor.
  • Patients who do not have **hematologic malignancies**. These are types of cancer that affect the blood, bone marrow, or lymph nodes.
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Investigated drugs

MaaT033 is an oral treatment that uses a mixture of healthy bacteria from the gut, known as fecal microbiotherapy. This therapy aims to restore the natural balance of bacteria in the intestines. In this clinical trial, MaaT033 is being tested to see if it can help prevent complications that might occur after a type of stem cell transplant called allogeneic hematopoietic cell transplantation. The goal is to improve the chances of survival for patients by maintaining a healthy gut environment.

What is already known about the treatment

MaaT033 – MaaT033 is an oral medication administered as a pooled fecal microbiotherapy, which means it uses a mixture of beneficial bacteria from healthy donors to help restore the balance of gut bacteria. It is currently being studied in a phase IIb clinical trial to see if it can help prevent complications in patients with blood cancers who are undergoing a type of stem cell transplant called allogeneic hematopoietic cell transplantation. The main goal of this trial is to determine if MaaT033 can improve survival rates one year after treatment. This medication works by introducing healthy bacteria into the gut, which can help support the immune system and reduce harmful inflammation. It is classified as a microbiome therapeutic, focusing on the beneficial effects of gut bacteria on health.

Investigated diseases

Hematologic Malignancies – Hematologic malignancies are cancers that begin in the cells of blood-forming tissue, such as the bone marrow, or in the cells of the immune system. These diseases include various types of leukemia, lymphoma, and myeloma. They typically involve the uncontrolled growth of abnormal blood cells, which can interfere with the production and function of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. The progression can vary significantly depending on the specific type of hematologic malignancy. Over time, these conditions can affect the body's ability to fight infections, carry oxygen, and control bleeding.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501831-18-00Protocol codeMPOH08Estimated enrolment388 patientsSponsorMaat Pharma

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).