Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorMaaT Pharma
About this trial
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
Qualifiers
Age > or = 18
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MaaT013
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov