Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:51 AM
Study NCT ID:
NCT07487402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurrent/Metastatic Hepatocellular Carcinoma
Sponsor:
Zhejiang University
Organization:
Study Overview
Official Title:
Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurrent/Metastatic Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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:
A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.
Detailed Description:
This is an open-label study. This study is indicated for unresectable recurrent/metastatic hepatocellular carcinoma.The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies.
1. Main research objectives:
To evaluate the safety and tolerability of metabolically armed GPC3 CAR-T cells injection (Meta10-GPC3) in patients with unresectable recurrent/metastatic hepatocellular carcinoma.
2. Secondary research objectives:
(1)To evaluate the efficacy of metabolically armed GPC3 CAR-T-cell therapy in unresectable recurrent/metastatic hepatocellular carcinoma.
(2) To assess the in vivo pharmacokinetic (PK) profile, phenotype, and functional activity of infused GPC3 CAR-T cells.
1. Main research objectives:
To evaluate the safety and tolerability of metabolically armed GPC3 CAR-T cells injection (Meta10-GPC3) in patients with unresectable recurrent/metastatic hepatocellular carcinoma.
2. Secondary research objectives:
(1)To evaluate the efficacy of metabolically armed GPC3 CAR-T-cell therapy in unresectable recurrent/metastatic hepatocellular carcinoma.
(2) To assess the in vivo pharmacokinetic (PK) profile, phenotype, and functional activity of infused GPC3 CAR-T cells.
Study Oversight
Has Oversight DMC:
False
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?: