FLYSYN in MRD Positive AML

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

February 7, 2017

Primary Completion Date

September 27, 2021

Study Completion Date

September 27, 2021

Conditions
Acute Myeloid Leukemia
Interventions
BIOLOGICAL

FLYSYN

"Cohort 1:~Patient 1-3: FLYSYN 0.5 mg/m² BSA\* day 1~Cohort 2:~Patient 4-6: FLYSYN 0.5 mg/m² BSA day 1 FLYSYN 1.0 mg/m² BSA day 2~Cohort 3:~Patient 7-9: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 4.5 mg/m² BSA day 2~Cohort 4:~Patient 10-12 and 13-18: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 14.5 mg/m² BSA day 2~Cohort 5:~Patient 19-21: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 44.5 mg/m² BSA day 2~Cohort 6:~Patient 22-24 and 25-31: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 14.5 mg/m² BSA day 2, FLYSYN 15 mg/m² BSA day 15, FLYSYN 15 mg/m² BSA day 29~\* The maximum upper limit for calculation of antibody dose is fixed at a body surface of 2.0 m², even if the calculated body surface exceeds this. In this study DLT are defined as the following treatment-related adverse events or laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03."

Trial Locations (5)

30625

Hannover Medical School, Hanover

69120

University Hospital of Heidelberg, Heidelberg

72076

University Hospital Tuebingen, Tübingen

89081

University Hospital Ulm, Ulm

04103

University of Leipzig Medical Center, Leipzig

All Listed Sponsors
lead

Synimmune GmbH

INDUSTRY

NCT02789254 - FLYSYN in MRD Positive AML | Biotech Hunter | Biotech Hunter