Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03888859
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2019-02-01
Brief Title:
ET1402L1-ARTEMIS2 T Cells in Alpha Fetoprotein AFP Expressing Hepatocellular Carcinoma
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Phase 1 Open-label Three Routes IV Intratumoral Injections and Intra-hepatic Artery Dose-escalation Clinical Study to Evaluate the Safety and Efficacy of ET1402L1-ARTEMIS2 T- Cells in AFP Expressing Hepatocellular Carcinoma HCC
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Clinical study to evaluate safety primary objectives and efficacy secondary objective of ET1402L1-ARTEMIS2 T cells in patients with alpha fetoprotein positive AFP hepatocellular carcinoma HCC
Detailed Description:
The molecular target for ET1402L1-ARTEMIS2 is human leukocyte antigen HLA -A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein AFP which is expressed on 60-80 percent of hepatocellular carcinoma HCC ARTEMIS2 is a second generation ARTEMIS receptor engineered with a human antibody domain against the anti-HLA-A02AFP complex This clinical study evaluates the safety and pharmacokinetics of ET1402L1-ARTEMIS2 T-cells in patients with HCC who have no available curative therapeutic options and a poor overall prognosis
Patients with lesions localized in liver will be enrolled in the intra-hepatic artery IA arm or Intratumoral Injections arm with the ET1402L1-ARTEMIS2 T-cells administered via intrahepatic artery catheter Patients with extrahepatic metastasis will be enrolled in the intravenous IV arm with the ET1402L1-ARTEMIS2 T-cells administered through intravenous infusion
Patients with lesions localized in liver will be enrolled in the intra-hepatic artery IA arm or Intratumoral Injections arm with the ET1402L1-ARTEMIS2 T-cells administered via intrahepatic artery catheter Patients with extrahepatic metastasis will be enrolled in the intravenous IV arm with the ET1402L1-ARTEMIS2 T-cells administered through intravenous infusion
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