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

Last updated: August 27, 2024
Sponsor: MaaT Pharma
Overall Status: Planned

Phase

N/A

Condition

N/A

Treatment

MaaT013

Clinical Study ID

NCT04768907
MPOHEAP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > or = 18

  • Grade III-IV gastro intestinal acute graft versus host disease with or withoutinvolvement of other organs:

  • patients resistant to corticosteroid (CS) and resistant to one or multiple lines oftreatments

  • 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 theinitial starting dose of CS is achieved.

  • acute GVHD with overlap syndrome

Exclusion

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 factorsupplementation is allowed

  • Absolute platelet count < 10 000/µL. Use of platelet infusion is allowed

  • Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinalperforation

  • Known allergy or intolerance to trehalose or maltodextrin

  • Pregnancy

  • Breastfeeding

Study Design

Treatment Group(s): 1
Primary Treatment: MaaT013
Phase:
Study Start date:
Estimated Completion Date:

Study 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

Connect with a study center

  • University Clinic - State Hospital of Innsbruck

    Innsbruck,
    Austria

    Planned

  • Ordensklinikum Linz Elisabethinen

    Linz,
    Austria

    Planned

  • Az Sint-Jan Brugge Av

    Brugge,
    Belgium

    Planned

  • Hub - Institut Jules Bordet

    Brussel,
    Belgium

    Planned

  • Foothills Medical Centre

    Calgary,
    Canada

    Planned

  • Chu Amiens Picardie Site Sud

    Amiens,
    France

    Planned

  • Chu Angers

    Angers,
    France

    Planned

  • Chu Besancon

    Besançon,
    France

    Planned

  • Chu Morvan

    Brest,
    France

    Planned

  • Chu de Caen

    Caen,
    France

    Planned

  • Chu Grenoble

    Grenoble,
    France

    Planned

  • Chu de Lille

    Lille,
    France

    Planned

  • Chu Limoges

    Limoges,
    France

    Planned

  • MaaT Pharma

    Lyon, 69007
    France

    Planned

  • Institut Paoli Calmettes

    Marseille,
    France

    Planned

  • Chu Montpellier - Hopital Saint Eloi

    Montpellier,
    France

    Planned

  • Chru Nancy

    Nancy,
    France

    Planned

  • Chu Nantes

    Nantes,
    France

    Planned

  • Chu de Nice - L'Archet 1

    Nice,
    France

    Planned

  • Aphp - Hopital Necker

    Paris,
    France

    Planned

  • Aphp - Hopital Sant Antoine

    Paris, 75012
    France

    Planned

  • Chu Bordeaux - Hopital Haut-Leveque

    Pessac,
    France

    Planned

  • Hopital Haut Leveque

    Pessac,
    France

    Planned

  • Chu Lyon Sud

    Pierre-Bénite,
    France

    Planned

  • Chu La Miletrie

    Poitiers,
    France

    Planned

  • Chu de Rennes - Hopital Pontchaillou

    Rennes,
    France

    Planned

  • Chu Rouen

    Rouen,
    France

    Planned

  • Crlcc Henri Becquerel

    Rouen,
    France

    Planned

  • Chu St Etienne

    Saint-Priest-en-Jarez,
    France

    Planned

  • Chu Strasbourg - Hopital de Hautepierre

    Strasbourg, 67200
    France

    Planned

  • Institut de Cancerologie de Strabsourg

    Strasbourg,
    France

    Planned

  • Iuct - Oncopole

    Toulouse,
    France

    Planned

  • Institut Gustave Roussy

    Villejuif,
    France

    Planned

  • Berlin University Medical Center - Charite Hospital

    Berlin,
    Germany

    Planned

  • University Hospital Essen

    Essen,
    Germany

    Planned

  • Saarlan University Medical Center

    Homburg,
    Germany

    Planned

  • University Hospital Mannheim

    Mannheim,
    Germany

    Planned

  • Ulm University Medical Center

    Ulm,
    Germany

    Planned

  • Aou Ospedali Riuniti

    Ancona,
    Italy

    Planned

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia,
    Italy

    Planned

  • Gemelli University Hospital

    Roma,
    Italy

    Planned

  • Aou Citta Della Salute E Della Scienza

    Torino,
    Italy

    Planned

  • Santa Maria Della Misericordia Hospital

    Udine,
    Italy

    Planned

  • Hospital General Universitario Morales Meseguer

    Murcia,
    Spain

    Planned

  • La Fe University Hospital

    Valencia,
    Spain

    Planned

  • University Hospital of Geneva

    Geneva,
    Switzerland

    Planned

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