31
Participants
Start Date
February 7, 2017
Primary Completion Date
September 27, 2021
Study Completion Date
September 27, 2021
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."
Hannover Medical School, Hanover
University Hospital of Heidelberg, Heidelberg
University Hospital Tuebingen, Tübingen
University Hospital Ulm, Ulm
University of Leipzig Medical Center, Leipzig
Synimmune GmbH
INDUSTRY