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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
New York
New York, New York, United States
RECRUITINGNew York
New York, New York, United States
RECRUITINGHong Kong is.
Hong Kong, Hong Kong
NOT_YET_RECRUITINGSafety and tolerability of SCG101
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Time frame: Start of SCG101 infusion until 100 days post SCG101 infusion
Tumor response of SCG101 (Phase 2)
Time frame: Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 years
Preliminary clinical efficacy of SCG101
Objective response rate
Time frame: Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Antiviral activity before and after SCG101 infusion
Based on changes in serum levels of HBsAg
Time frame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Based on changes in serum from the liver function
Time frame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Persistence of viral vector copy number (VCN) after SCG101 infusion
Time frame: Start of SCG101 infusion until disease progression, an average of 24 months.
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Hong Kong NT
Hong Kong, Hong Kong
RECRUITINGSingapore
Singapore, Singapore
RECRUITINGSingapore
Singapore, Singapore
RECRUITING