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

A regiszterben nem jelölt feltételek

• Main Inclusion Criteria:
• Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
• Subjects with HCC who have received at least 2 standard systemic therapies
• HLA-A *02
• BCLC stage B or C
• Child-pugh score ≤ 7
• Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
• Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
• Life expectancy of 3 months or greater
• Ability to provide informed consent form
• Ability to comply with all the study procedures
  • Main Exclusion Criteria:
• Subjects with history of another primary cancer
• Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
• Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
• Known history of neurological or mental disorder, including epilepsy or dementia
• Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
• 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, CAR T/TCR T cell therapy
• Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
• Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation