Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756648
Status:
RECRUITING
Last Update Posted:
2023-07-17
First Post:
2021-02-11
Brief Title:
Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
An Open Dose EscalationDose Exploration Phase I Study to Evaluate the Safety Tolerability and Pharmacokinetics of SingleMultiple Infusion of CT0180 Injection in Patients With Advanced Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-07
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 Phase I Clinical Study ofCT0180 cells in Patients with Advanced Hepatocellular Carcinoma
Detailed Description:
Primary objectives
Evaluate the safety and tolerance of CT0180 cells in patients with advanced hepatocellular carcinoma within 28 days after the first infusion
Secondary objectives
Evaluate the metabolic kinetics of CT0180 cells Evaluate overall safety and tolerability Evaluate the initial efficacy of CT0180 cell infusion in the treatment of advanced hepatocellular carcinoma with positive Glypican-3GPC3 expression
Evaluate the safety and tolerance of CT0180 cells in patients with advanced hepatocellular carcinoma within 28 days after the first infusion
Secondary objectives
Evaluate the metabolic kinetics of CT0180 cells Evaluate overall safety and tolerability Evaluate the initial efficacy of CT0180 cell infusion in the treatment of advanced hepatocellular carcinoma with positive Glypican-3GPC3 expression
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