Ignite Creation Date:
2024-05-06 @ 9:50 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03084380
Status:
UNKNOWN
Last Update Posted:
2017-03-20
First Post:
2017-03-05
Brief Title:
Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma HCC
Sponsor:
Xinqiao Hospital of Chongqing
Organization:
Xinqiao Hospital of Chongqing
Study Overview
Official Title:
Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
NOT_YET_RECRUITING
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 goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ΞΆ-tEGFR chimeric antigen receptor CAR-modified T CAR-T cells in treating patients with GPC3-positive advanced hepatocellular carcinoma HCC
Detailed Description:
Primary Objectives
1 To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma
2 To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection
Secondary Objectives
1 To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma
2 To monitor the serum cytokine and expression level of tumor markers such as AFP CEA and GPC3
3 To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells
1 To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma
2 To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection
Secondary Objectives
1 To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma
2 To monitor the serum cytokine and expression level of tumor markers such as AFP CEA and GPC3
3 To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells
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