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

July 3, 2023 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

Available

Conditions

Intervention / Treatment

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

Expanded Access

Expanded Access Type

  • 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 Locations

  • France
      • Amiens, France
        • Available
        • CHU Amiens Picardie site Sud
      • Angers, France
        • Available
        • CHU Angers
      • Brest, France
        • Available
        • CHU Morvan
      • Caen, France
        • Available
        • CHU de Caen
      • Grenoble, France
        • Available
        • CHU Grenoble
      • Lille, France
        • Available
        • CHU de Lille
      • Lyon, France, 69007
      • Marseille, France
        • Available
        • Institut Paoli Calmettes
      • Montpellier, France
        • Available
        • CHU Montpellier - Hôpital Saint Eloi
      • Nice, France
        • Available
        • CHU de Nice - l'Archet 1
      • Paris, France, 75012
        • Available
        • Aphp - Hopital Sant Antoine
      • Pessac, France
        • Available
        • Hopital Haut Leveque
      • Pierre-Bénite, France
        • Available
        • CHU Lyon Sud
      • Poitiers, France
        • Available
        • CHU La Miletrie
      • Rennes, France
        • Available
        • CHU de Rennes - Hôpital Pontchaillou
      • Rouen, France
        • Available
        • CHU Rouen
      • Rouen, France
        • Available
        • Crlcc Henri Becquerel
      • Strasbourg, France
        • Available
        • Institut de Cancerologie de Strabsourg
      • Toulouse, France
        • Available
        • IUCT - Oncopole
      • Villejuif, France
        • Available
        • Institut Gustave Roussy

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

Ages Eligible for Study

16 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

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

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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