NCT05417932

A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: SCG Cell Therapy Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma

Detailed description

This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels. In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.

Conditions

• Hepatitis B Virus Related Hepatocellular Carcinoma
• Hepatocellular Carcinoma Recurrent

Interventions

Type	Name	Description
BIOLOGICAL	SCG101	Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

Timeline

• Start date: 2022-10-26
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2022-06-14
• Last updated: 2025-02-18

Locations

6 sites across 3 countries: United States, Hong Kong, Singapore

Regulatory

• FDA-regulated drug study