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drugset / Trial / NCT07803978

Prospective Randomized Controlled Study: Amimaitosai Injection Combined With Corticosteroids for Gastrointestinal aGVHD

NCT07803978 ↗

Phase 0 Enrolling by invitation 60 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study focuses on patients with gastrointestinal-dominant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation. AmiMetosai Injection combined with corticosteroids is administered as first-line treatment. The objective is to evaluate the efficacy and safety of AmiMetosai Injection combined with corticosteroids for the treatment of gastrointestinal aGVHD.

Timeline

Start
2026-05-01
Primary completion
2029-05-01
Completion
2029-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amimaitosai injection Unknown 1e+06 cells/kg —
Subject Methylprednisolone Other / unclassified 1 mg/kg —
Subject Methylprednisolone Other / unclassified 2 mg/kg —

Indications

acute graft versus host disease