drugset / Trial / NCT06645314
Study on the Safety and Efficacy of BST06 Injection in the Treatment of Advanced Hepatocellular Carcinoma
Phase 0
Not yet recruiting
16 enrolled
BioSyngen Pte Ltd
South China Hospital of Shenzhen University · collab
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2024-11-30
- Primary completion
- 2026-08-31
- Completion
- 2027-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BST06 | Cell therapy | 3e+09 cells | Intravenous |
| Subject | BST06 | Cell therapy | 3e+10 cells | Intravenous |