Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502082
Status:
TERMINATED
Last Update Posted:
2024-04-05
First Post:
2020-07-22
Brief Title:
Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma ARYA-1
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 ET140203 T Cells and Determine the Recommended Phase II Dose RP2D in Adults With Advanced Hepatocellular Carcinoma HCC ARYA-1
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Directing efforts to the pediatric study ARYA-2 for this product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open-label dose escalation multi-center Phase I II study to assess the safety of an autologous T-cell product ET140203 in adult subjects with Alpha-fetoprotein AFP-positiveHuman Leukocyte Antigen HLA A-2-positive advanced hepatocellular carcinoma HCC
Detailed Description:
The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma HCC ET140203 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