drugset / Trial / NCT04769895

MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients

NCT04769895

Phase 3 Active not recruiting 66 enrolled MaaT Pharma
NaSingle-groupOpen-labelTreatment

Summary

MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.

Timeline

Start
2022-03-25
Primary completion
2024-11
Completion
2025-11

Drugs

EvaluationDrugModalityDoseRoute
Subject MaaT013 Other / unclassified Rectal