A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

Recruitment & Eligibility

Inclusion Criteria

Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
Subjects with HCC who have received standard systemic therapies
HLA-A *02
BCLC stage B or C
Child-pugh score ≤ 7 ol
Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
Have at least one measurable leasion at baseline as per mRECIST and iRECIST
Life expectancy of 3 months or greater
The organ function is in good condition.

Exclusion Criteria

Subjects with history of another primary cancer within 5 years
Central nervous system metastasis and clinically significant central nervous system disease
Previous or current coexistence of hepatic encephalopathy
Currently present with symptomatic third space fluid accumulation
Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
Known history of neurological or mental disorder, including epilepsy or dementia
Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy
Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Study & Design

Arm && Interventions

Group	Intervention	Description
SCG101	SCG101	-

Primary Outcome Measures

Name	Time	Method
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).	Start of SCG101 infusion until disease progression or 12 months post infusion	Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria
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).	Start of SCG101 infusion until disease progression or 12 months post infusion	Per mRECIST and iRECIST
Change in pharmacodynamics markers (PD) before and after SCG101 infusion	Start of SCG101 infusion until disease progression, an average of 24 months	Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP
Persistences of viral vector copy number (VCN) after SCG101 infusion	Start of SCG101 infusion until disease progression, an average of 24 months

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility