Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645314
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Study on the Safety and Efficacy of BST06 Injection in the Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Safety and Efficacy of BST06 Injection in the Treatment of Advanced Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is an exploratory clinical trial initiated by an open single arm researcher to evaluate the safety tolerability and preliminary efficacy of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects This study plans to apply Bayesian Optimal Interval BOIN design with at least 2 and up to 8 DLT assessable subjects in each dose group who must complete a 28 day DLT assessment period The study plan includes 2 dose groups 5x10 9 and 3x10 10 BST06 cells
Detailed Description:
Main purpose
Evaluate the safety and tolerability of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects
Secondary purpose
1 Evaluate the preliminary effectiveness of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects
2 Evaluate the pharmacokinetic PK characteristics of BST06 injection
Exploratory purpose
Explore the Pharmacodynamics PD characteristics of BST06 injection
Evaluate the safety and tolerability of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects
Secondary purpose
1 Evaluate the preliminary effectiveness of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects
2 Evaluate the pharmacokinetic PK characteristics of BST06 injection
Exploratory purpose
Explore the Pharmacodynamics PD characteristics of BST06 injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None