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

NCT06645314 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-10-16

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • South China Hospital of Shenzhen University

    collaborator UNKNOWN

  • BioSyngen Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Mingyong Han, PhD · South China Hospital of Shenzhen Univercity

  • Yuqing Li, PhD · South China Hospital of Shenzhen Univercity

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2026-08-31
Completion
2027-08-31

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Entities

Diseases

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 NCT06645314 on ClinicalTrials.gov