NCT06173726

Investigator-initiated Phase I Exploratory Clinical Study of the Safety, Tolerability, and Efficacy of BST02 Injection in the Treatment of Locally Advanced/Metastatic Liver Cancer

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: BioSyngen Pte Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, investigator-initiated Phase I clinical trial to evaluate the safety, tolerability, and initial efficacy of BST02 injection in patients with locally advanced / metastatic liver cancer. This study includes a dose escalation study and a dose extension study, which will observe the effects of different IL-2 injection doses on the safety and efficacy of BST02. After signing the informed consent, the subjects will roughly go through two periods: the main study period and the long-term follow-up period. The main study period includes screening period, treatment and safety observation period, and follow-up period

Conditions

• Locally Advanced/Metastatic Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BST02 Injection	The TIL used for tumor tissue surgical sampling of qualified subjects was used to prepare BST02 injection, and the subjects who successfully received the surgical sampling were considered to be enrolled. In the study process, cell transfusions were recorded as day 0 of the study. On the 3rd day (D-3) before infusion of BST02 injection, it is necessary to receive eluvial pretreatment. Considering that this product is unmodified autologous T lymphocytes, previous studies have shown that low-intensity cyclophosphamide can stimulate their proliferation in vivo. Therefore, the cyclophosphamide (Cy) single-drug regimen is recommended: Cy 250mg\~1.5g/m2, a single intravenous infusion

Timeline

• Start date: 2023-12-05
• Primary completion: 2026-12-05
• Completion: 2026-12-05
• First posted: 2023-12-18
• Last updated: 2023-12-18

Locations

1 site across 1 country: China