Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host … (NCT04768907) | Clinical Trial Compass
AVAILABLENot Applicable
Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease
Austria, Belgium, Canada
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.