Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02854839
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2016-07-28
Brief Title:
A Study of MG4101 Allogeneic Natural Killer Cell for Intermediate-stage of Hepatocellular Carcinoma
Sponsor:
GC Cell Corporation
Organization:
GC Cell Corporation
Study Overview
Official Title:
Multi-center Open Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of MG4101 in Hepatocellular Carcinoma After TACE
Status:
COMPLETED
Status Verified Date:
2018-10
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:
None
Brief Summary:
The propose of this study is evaluate the safety and efficacy of MG4101 allogeneic Natural killer cells in patients with hepatocellular carcinoma HCC after transarterial chemoembolization TACE
Detailed Description:
This is randomized multi-center open-labeled Phase 2a study in patients with HCC after transarterial chemoembolization TACE A total of 78 patients will be randomized11 into one of the two group to receive adjuvant therapy using MG4101 allogeneic Natural killer cells Treatment group or no adjuvant therapy Control group
Patients who were assigned Treatment group will receive 2 cycles of MG4101 each cycle is 3 treatments at a frequency of once per week between each cycle has 3 weeks of withdrawal period After treatment period patients will undergo follow up for progression and survival every 12 weeks 7 days and follow up 1 year after the last patients enrollment date
The Control groups patients will will undergo follow up for progression and survival every 12 weeks 7 days and follow up 1 year after the last patients enrollment date
Patients who were assigned Treatment group will receive 2 cycles of MG4101 each cycle is 3 treatments at a frequency of once per week between each cycle has 3 weeks of withdrawal period After treatment period patients will undergo follow up for progression and survival every 12 weeks 7 days and follow up 1 year after the last patients enrollment date
The Control groups patients will will undergo follow up for progression and survival every 12 weeks 7 days and follow up 1 year after the last patients enrollment date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None