NCT06645314

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: BioSyngen Pte Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-30
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2024-10-16
• Last updated: 2024-10-16