Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-22 @ 8:12 PM
Study NCT ID:
NCT06526832
Status:
UNKNOWN
Last Update Posted:
2024-07-30
First Post:
2023-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of BST02 in Treating Locally Advanced Liver Cancer
Sponsor:
BioSyngen Pte Ltd
Organization:
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:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
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 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:
False
Is a FDA Regulated Drug?:
True
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?: