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

Sponsor
MaaT Pharma (Industry)
Overall Status
Available
CT.gov ID
NCT04768907
Collaborator
(none)
20
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Expanded Access

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Amiens Picardie Site Sud Amiens France
    2 Chu Angers Angers France
    3 Chu Morvan Brest France
    4 Chu de Caen Caen France
    5 Chu Grenoble Grenoble France
    6 Chu de Lille Lille France
    7 MaaT Pharma Lyon France 69007
    8 Institut Paoli Calmettes Marseille France
    9 Chu Montpellier - Hopital Saint Eloi Montpellier France
    10 Chu de Nice - L'Archet 1 Nice France
    11 Aphp - Hopital Sant Antoine Paris France 75012
    12 Hopital Haut Leveque Pessac France
    13 Chu Lyon Sud Pierre-Bénite France
    14 Chu La Miletrie Poitiers France
    15 Chu de Rennes - Hopital Pontchaillou Rennes France
    16 Chu Rouen Rouen France
    17 Crlcc Henri Becquerel Rouen France
    18 Institut de Cancerologie de Strabsourg Strasbourg France
    19 Iuct - Oncopole Toulouse France
    20 Institut Gustave Roussy Villejuif France

    Sponsors and Collaborators

    • MaaT Pharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MaaT Pharma
    ClinicalTrials.gov Identifier:
    NCT04768907
    Other Study ID Numbers:
    • MPOHEAP
    First Posted:
    Feb 24, 2021
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Jun 22, 2022