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 range18 Years
SexALL
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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