Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease
ATLAS
1 other identifier
expanded_access
N/A
8 countries
46
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.
Trial Health
Trial Health Score
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46 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedAugust 28, 2024
August 1, 2024
February 22, 2021
August 27, 2024
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MaaT Pharmalead
Study Sites (46)
University Clinic - State Hospital of Innsbruck
Innsbruck, Austria
Ordensklinikum Linz Elisabethinen
Linz, Austria
Az Sint-Jan Brugge Av
Bruges, Belgium
Hub - Institut Jules Bordet
Brussels, Belgium
Foothills Medical Centre
Calgary, Canada
Chu Amiens Picardie Site Sud
Amiens, France
Chu Angers
Angers, France
Chu Besancon
Besançon, France
Chu Morvan
Brest, France
Chu de Caen
Caen, France
Chu Grenoble
Grenoble, France
Chu de Lille
Lille, France
Chu Limoges
Limoges, France
MaaT Pharma
Lyon, 69007, France
Institut Paoli Calmettes
Marseille, France
Chu Montpellier - Hopital Saint Eloi
Montpellier, France
Chru Nancy
Nancy, France
Chu Nantes
Nantes, France
Chu de Nice - L'Archet 1
Nice, France
Aphp - Hopital Sant Antoine
Paris, 75012, France
Aphp - Hopital Necker
Paris, France
Chu Bordeaux - Hopital Haut-Leveque
Pessac, France
Hopital Haut Leveque
Pessac, France
Chu Lyon Sud
Pierre-Bénite, France
Chu La Miletrie
Poitiers, France
Chu de Rennes - Hopital Pontchaillou
Rennes, France
Chu Rouen
Rouen, France
Crlcc Henri Becquerel
Rouen, France
Chu St Etienne
Saint-Priest-en-Jarez, France
Chu Strasbourg - Hopital de Hautepierre
Strasbourg, 67200, France
Institut de Cancerologie de Strabsourg
Strasbourg, France
Iuct - Oncopole
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Berlin University Medical Center - Charite Hospital
Berlin, Germany
University Hospital Essen
Essen, Germany
Saarlan University Medical Center
Homburg, Germany
University Hospital Mannheim
Mannheim, Germany
Ulm University Medical Center
Ulm, Germany
Aou Ospedali Riuniti
Ancona, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy
Gemelli University Hospital
Roma, Italy
Aou Citta Della Salute E Della Scienza
Torino, Italy
Santa Maria Della Misericordia Hospital
Udine, Italy
Hospital General Universitario Morales Meseguer
Murcia, Spain
La Fe University Hospital
Valencia, Spain
University Hospital of Geneva
Geneva, Switzerland