Acute Graft Versus Host Disease in IntestineATLASNCT04768907
Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease
A study testing MaaT013 in people with Acute Graft Versus Host Disease in Intestine and Steroid Refractory GVHD, run by MaaT Pharma at 46 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD
- What is being tested?
- MaaT013
- How many people
- Not given
- Where
- 46 sitesin 8 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known allergy or intolerance to trehalose or maltodextrin
- Pregnancy
- Breastfeeding
Trial locations and contacts
46 sites in 8 countries.
46 sites in 8 countries
France28 sites
- Available
Chu Amiens Picardie Site Sud
Amiens
- Available
Chu Angers
Angers
- Available
Chu Besancon
Besançon
- Available
Chu Morvan
Brest
- Available
Chu de Caen
Caen
- Available
Chu Grenoble
Grenoble
- Available
Chu de Lille
Lille
- Available
Chu Limoges
Limoges
- Available
MaaT Pharma
Lyon, 69007
MaaT Pharma, atu@maat-pharma.com
- Available
Institut Paoli Calmettes
Marseille
- Available
Chu Montpellier - Hopital Saint Eloi
Montpellier
- Available
Chru Nancy
Nancy
- Available
Chu Nantes
Nantes
- Available
Chu de Nice - L'Archet 1
Nice
- Available
Aphp - Hopital Sant Antoine
Paris, 75012
- Available
Aphp - Hopital Necker
Paris
- Available
Chu Bordeaux - Hopital Haut-Leveque
Pessac
- Available
Hopital Haut Leveque
Pessac
- Available
Chu Lyon Sud
Pierre-Bénite
- Available
Chu La Miletrie
Poitiers
- Available
Chu de Rennes - Hopital Pontchaillou
Rennes
- Available
Chu Rouen
Rouen
- Available
Crlcc Henri Becquerel
Rouen
- Available
Chu St Etienne
Saint-Priest-en-Jarez
- Available
Chu Strasbourg - Hopital de Hautepierre
Strasbourg, 67200
- Available
Institut de Cancerologie de Strabsourg
Strasbourg
- Available
Iuct - Oncopole
Toulouse
- Available
Institut Gustave Roussy
Villejuif
Germany5 sites
- Available
Berlin University Medical Center - Charite Hospital
Berlin
- Available
University Hospital Essen
Essen
- Available
Saarlan University Medical Center
Homburg
- Available
University Hospital Mannheim
Mannheim
- Available
Ulm University Medical Center
Ulm
Italy5 sites
- Available
Aou Ospedali Riuniti
Ancona
- Available
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia
- Available
Gemelli University Hospital
Roma
- Available
Aou Citta Della Salute E Della Scienza
Torino
- Available
Santa Maria Della Misericordia Hospital
Udine
Austria2 sites
- Available
University Clinic - State Hospital of Innsbruck
Innsbruck
- Available
Ordensklinikum Linz Elisabethinen
Linz
Belgium2 sites
- Available
Az Sint-Jan Brugge Av
Bruges
- Available
Hub - Institut Jules Bordet
Brussels
Spain2 sites
- Available
Hospital General Universitario Morales Meseguer
Murcia
- Available
La Fe University Hospital
Valencia
About this study
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.
Read the 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
- Being tested
- MaaT013
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaaT013Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host Disease in IntestineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- MaaT Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768907
- Sponsor's protocol ID
- MPOHEAP
- Acronym
- ATLAS
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT04768907
- Acronym / sponsor ID
- ATLAS / MPOHEAP
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- MaaT PharmaIndustry (pharma, biotech, devices)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaaT013 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MaaT013 in people with Acute Graft Versus Host Disease in Intestine and Steroid Refractory GVHD, run by MaaT Pharma at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in France, Germany, Italy, Austria, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MaaT Pharma (+33(0)428291400, atu@maat-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.