Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease (ATLAS)

August 27, 2024 updated by: MaaT Pharma

MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned.

In the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute Graft-versus-Host Disease (aGvHD) is a serious and life-threatening disease that arises as a complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT). At the onset of aGvHD, skin is the most frequently affected region (80% of patients) while GI tract or liver are involved in about 50% of patients (Martin 1990). aGvHD symptoms for the lower GI tract include watery diarrhea (≥500 mL), severe abdominal pain or bloody diarrhea (Ferrara 2009). While the incidence of severe GI-aGvHD has slightly decreased during the past decade, treatment remains unsuccessful in most cases (Gooley 2010, Castilla Llorente 2014), with a 2-months overall survival (OS) rate of 22% in steroid non-responsive or steroid refractory (SR) patients, non-responders to ruxolitinib (Jagasia 2020).

MaaT013 (pooled allogeneic fecal microbiota) is a live biotherapeutic product being developed by MaaT Pharma (Lyon, France) for the treatment of steroid-resistant, gastrointestinal aGvHD (SR-GI-aGvHD) adult patients with refractory, not eligible or who have failed second-line systemic therapy.

MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of SR-GI-aGvHD. In addition, a pivotal Phase III study (ARES trial) is planned

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Available
        • University Clinic - State Hospital of Innsbruck
      • Linz, Austria
        • Available
        • Ordensklinikum Linz Elisabethinen
  • Belgium
      • Brugge, Belgium
        • Available
        • AZ Sint-Jan Brugge AV
      • Brussel, Belgium
        • Available
        • HUB - Institut Jules Bordet
  • Canada
      • Calgary, Canada
        • Available
        • Foothills Medical Centre
  • France
      • Amiens, France
        • Available
        • CHU Amiens Picardie Site Sud
      • Angers, France
        • Available
        • CHU Angers
      • Besançon, France
        • Available
        • CHU Besançon
      • Brest, France
        • Available
        • CHU Morvan
      • Caen, France
        • Available
        • CHU de Caen
      • Grenoble, France
        • Available
        • CHU Grenoble
      • Lille, France
        • Available
        • CHU de Lille
      • Limoges, France
        • Available
        • CHU Limoges
      • Lyon, France, 69007
        • Available
        • MaaT Pharma
      • Marseille, France
        • Available
        • Institut Paoli Calmettes
      • Montpellier, France
        • Available
        • CHU Montpellier - Hôpital Saint Eloi
      • Nancy, France
        • Available
        • Chru Nancy
      • Nantes, France
        • Available
        • CHU Nantes
      • Nice, France
        • Available
        • Chu de Nice - L'Archet 1
      • Paris, France, 75012
        • Available
        • Aphp - Hopital Sant Antoine
      • Paris, France
        • Available
        • APHP - Hopital Necker
      • Pessac, France
        • Available
        • Hopital Haut Leveque
      • Pessac, France
        • Available
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Pierre-Bénite, France
        • Available
        • CHU Lyon Sud
      • Poitiers, France
        • Available
        • Chu La Miletrie
      • Rennes, France
        • Available
        • CHU de Rennes - Hopital Pontchaillou
      • Rouen, France
        • Available
        • CHU Rouen
      • Rouen, France
        • Available
        • Crlcc Henri Becquerel
      • Saint-Priest-en-Jarez, France
        • Available
        • CHU ST Etienne
      • Strasbourg, France
        • Available
        • Institut de Cancerologie de Strabsourg
      • Strasbourg, France, 67200
        • Available
        • Chu Strasbourg - Hôpital de Hautepierre
      • Toulouse, France
        • Available
        • IUCT - Oncopole
      • Villejuif, France
        • Available
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany
        • Available
        • Berlin University Medical Center - Charite Hospital
      • Essen, Germany
        • Available
        • University Hospital Essen
      • Homburg, Germany
        • Available
        • Saarlan University Medical Center
      • Mannheim, Germany
        • Available
        • University Hospital Mannheim
      • Ulm, Germany
        • Available
        • Ulm University Medical Center
  • Italy
      • Ancona, Italy
        • Available
        • AOU Ospedali Riuniti
      • Pavia, Italy
        • Available
        • Fondazione I.R.C.C.S. Policlinico San Matteo
      • Roma, Italy
        • Available
        • Gemelli University Hospital
      • Torino, Italy
        • Available
        • AOU Città della Salute e della Scienza
      • Udine, Italy
        • Available
        • Santa Maria della Misericordia Hospital
  • Spain
      • Murcia, Spain
        • Available
        • Hospital General Universitario Morales Meseguer
      • Valencia, Spain
        • Available
        • La Fe University Hospital
  • Switzerland
      • Geneva, Switzerland
        • Available
        • University Hospital of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Age > or = 18
  • Grade III-IV gastro intestinal acute graft versus host disease with or without involvement of other organs:
  • patients resistant to corticosteroid (CS) and resistant to one or multiple lines of treatments
  • patients who cannot tolerate CS tapering, i.e., begin of CS at 2.0 mg/kg/d, demonstrate response, but show disease progress before a 50% decrease from the initial starting dose of CS is achieved.
  • acute GVHD with overlap syndrome

Exclusion Criteria:

  • Active uncontrolled infection
  • Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
  • Current or past veno-occlusive disease or other uncontrolled complication
  • Absolute neutrophil count <500/µL for 3 consecutive days. Use of growth factor supplementation is allowed
  • Absolute platelet count < 10 000/µL. Use of platelet infusion is allowed
  • Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation
  • Known allergy or intolerance to trehalose or maltodextrin
  • Pregnancy
  • Breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MaaT Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MPOHEAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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