drugset / Trial / NCT05709093

A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)

NCT05709093

Phase 3 Terminated 10 enrolled TJ Biopharma Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in treatment-naïve subjects with intermediate- and high-risk MDS.

Timeline

Start
2023-03-30
Primary completion
2024-04-01
Completion
2024-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lemzoparlimab Monoclonal antibody 30 mg/kg Intravenous
Comparator Azacitidine Other / unclassified 75 mg/m2 Subcutaneous