Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease

Status:

AVAILABLE

Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease

Lead Sponsor:

MaaT Pharma

Conditions:

Acute Graft Versus Host Disease in Intestine

Steroid Refractory GVHD

Eligibility:

All Genders

18+ years

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 ...

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...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04768907

Last Update

August 28 2024

Active Locations (46)

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Page 1 of 12 (46 locations)

University Clinic - State Hospital of Innsbruck

Innsbruck, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Az Sint-Jan Brugge Av

Bruges, Belgium