Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06645314
EARLY_PHASE1

Study on the Safety and Efficacy of BST06 Injection in the Treatment of Advanced Hepatocellular Carcinoma

Sponsor: BioSyngen Pte Ltd

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2024-11-30

Completion Date

2027-08-31

Last Updated

2024-10-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

Group A

3.0 × 10 \^ 9 BST06 cells, intravenous infusion,at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled

BIOLOGICAL

Group B

3.0 × 10 \^ 10 BST06 cells, intravenous infusion, at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled