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

October, 2022

Scientific title

A Phase 1/ 2, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Summary

This Phase 1/ 2 study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma

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

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Intervention model description: SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma, Masking: None (Open Label),

Conditions

Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent

Other study ID numbers

SCG101-UR-103

Choose trial site (5)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
Singapore 169610