Last updated on October 2018

FLYSYN in MRD Positive AML


Brief description of study

This is a first in human, prospective, monocentric, 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.

Detailed Study Description

Cohort 1:

Patient 1-3: FLYSYN 0.5 mg/m body surface area (BSA) day 1

Cohort 2:

Patient 4-6: FLYSYN 0.5 mg/m body surface area (BSA) day 1 FLYSYN 1.0 mg/m BSA day 2

Cohort 3:

Patient 7-9: FLYSYN 0.5 mg/m body surface area (BSA) day 1, FLYSYN 4.5 mg/m BSA day 2

Cohort 4:

Patient 10-12 and 13-28: FLYSYN 0.5 mg/m body surface area (BSA) day 1, FLYSYN 14.5 mg/m BSA day 2

Clinical Study Identifier: NCT02789254

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