Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02789254
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2016-05-13
Brief Title:
FLYSYN in MRD Positive AML
Sponsor:
Synimmune GmbH
Organization:
Synimmune GmbH
Study Overview
Official Title:
First in Man Study to Evaluate the Safety Tolerability and Preliminary Efficacy of the Fc-optimized FLT3 Antibody FLYSYN for the Treatment of Acute Myeloid Leukemia Patients With Minimal Residual Disease
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLYSYN-101
Brief 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
Detailed Description:
Cohort 1
Patient 1-3 FLYSYN 05 mgm² body surface area BSA day 1
Cohort 2
Patient 4-6 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 10 mgm² BSA day 2
Cohort 3
Patient 7-9 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 45 mgm² BSA day 2
Cohort 4
Patient 10-12 and 13-18 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 145 mgm² BSA day 2
Cohort 5
Patient 19-21 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 445 mgm² BSA day 2
Cohort 6
Patient 22-24 and 25 -31 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 145 mgm² BSA day 2 FLYSYN 15 mgm² BSA day 15 FLYSYN 15 mgm² BSA day 29
Patient 1-3 FLYSYN 05 mgm² body surface area BSA day 1
Cohort 2
Patient 4-6 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 10 mgm² BSA day 2
Cohort 3
Patient 7-9 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 45 mgm² BSA day 2
Cohort 4
Patient 10-12 and 13-18 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 145 mgm² BSA day 2
Cohort 5
Patient 19-21 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 445 mgm² BSA day 2
Cohort 6
Patient 22-24 and 25 -31 FLYSYN 05 mgm² body surface area BSA day 1 FLYSYN 145 mgm² BSA day 2 FLYSYN 15 mgm² BSA day 15 FLYSYN 15 mgm² BSA day 29
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None