Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03998033
Status:
TERMINATED
Last Update Posted:
2022-08-23
First Post:
2019-06-07
Brief Title:
Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma
Sponsor:
Eureka Therapeutics Inc
Organization:
Eureka Therapeutics Inc
Study Overview
Official Title:
An Open-Label Dose Escalation Multi-Center Phase III Research Trial to Assess the Safety of ET140202 T Cells and Determine the Recommended Phase II Dose RP2D in Adults With Advanced Hepatocellular Carcinoma HCC
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reallocation of resources to new HCC study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ET-109
Brief Summary:
This is a open-label dose escalation multi-center Phase I Phase II study to assess the safety of an autologous T-cell product ET140202 in adult subjects with advanced Alpha-fetoprotein AFP positiveHuman Leukocyte Antigen HLA A-2 positive Hepatocellular Carcinoma HCC
Detailed Description:
The purpose of this study is to investigate a genetically modified autologous T-cell therapy for advanced hepatocellular carcinoma HCC ET140202 T cells are autologous T cells genetically modified to carry a TCR-mimic TCRm construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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