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

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

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.

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