drugset / Trial / NCT02789254

FLYSYN in MRD Positive AML

NCT02789254 ↗

Phase 1/2 Completed 31 enrolled Synimmune GmbH
NaSingle-groupOpen-labelTreatment

Summary

This is a first in human, prospective, multicentric, nonrandomized, open-label study to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of the Fc-optimized antibody FLYSYN as monotherapy in adult subjects.

Timeline

Start
2017-02-07
Primary completion
2021-09-27
Completion
2021-09-27

Drugs

EvaluationDrugModalityDoseRoute
Subject FLYSYN Unknown 0.5 mg/m2 Intravenous
Subject FLYSYN Unknown 1.5 mg/m2 Intravenous
Subject FLYSYN Unknown 5 mg/m2 Intravenous
Subject FLYSYN Unknown 15 mg/m2 Intravenous
Subject FLYSYN Unknown 45 mg/m2 Intravenous