This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Beijing
Beijing, Beijing Municipality, China
RECRUITINGGuangzhou
Guangzhou, Guangdong, China
RECRUITINGZhengzhou
Zhengzhou, Henan, China
Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria
Time frame: Start of SCG101 infusion until disease progression or 12 months post infusion
The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).
Per mRECIST and iRECIST
Time frame: Start of SCG101 infusion until disease progression or 12 months post infusion
Change in pharmacodynamics markers (PD) before and after SCG101 infusion
Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP
Time frame: Start of SCG101 infusion until disease progression, an average of 24 months
Persistences 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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Changchun
Changchun, Jilin, China
RECRUITINGShenyang
Shenyang, Liaoning, China
RECRUITINGJi'nan
Ji'nan, Shandong, China
RECRUITINGShanghai
Shanghai, Shanghai Municipality, China
RECRUITING