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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

NCT06173726 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-12-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • BioSyngen Pte Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2026-12-05
Completion
2026-12-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173726 on ClinicalTrials.gov