Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526832
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-09-06
Brief Title:
A Phase 1 Study of BST02 in Treating Locally Advanced Liver Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Dose-Escalation and Dose-Expansion Study Evaluating the Safety Tolerability and Efficacy of BST02 in Treating Locally Advanced Liver Cancer
Status:
RECRUITING
Status Verified Date:
2023-09
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 goal of this clinical trial is to investigate the BST02 a tumor infiltrating lymphocyte product collected from the locally advanced liver cancer subjects
The main questions it aims to answer are
1 Safety and tolerability of BST02
2 Preliminary efficacy of BST02 Participants will receive a cytoreductive surgery to collect samples for the manufacture of BST02
Participants will receive BST02 infusion followed by IL-2 infusion Blood samples will be collected for the analysis of PK and safety
The main questions it aims to answer are
1 Safety and tolerability of BST02
2 Preliminary efficacy of BST02 Participants will receive a cytoreductive surgery to collect samples for the manufacture of BST02
Participants will receive BST02 infusion followed by IL-2 infusion Blood samples will be collected for the analysis of PK and safety
Detailed Description:
None
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