A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
- Trial number:
-
NCT05417932
- Trial phase:
- 1, 2
- Study type:
- Immunotherapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Main
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
Subjects with history of another primary cancerUntreated 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