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

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

December 5, 2023

Primary Completion Date

December 5, 2026

Study Completion Date

December 5, 2026

Conditions
Locally Advanced/Metastatic Liver Cancer
Interventions
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"

Trial Locations (1)

518000

Shenzhen Second People's Hospital, Shenzhen

All Listed Sponsors
collaborator

Shenzhen Second People's Hospital

OTHER

lead

BioSyngen Pte Ltd

INDUSTRY

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 | Biotech Hunter | Biotech Hunter