Tests SCG101 in adults with hepatitis B-related liver cancer
Tests SCG101, a biological treatment, in adults with liver cancer linked to hepatitis B.
Plain-language title generated from the registry record
Registry title: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Key facts
- Where
- New York, United StatesSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05417932, who can take part
Where in United States
- New YorkNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SCG Cell Therapy Pte. Ltd.
- Trial code
- NCT05417932
- Record updated
- 18 February 2025
- Original description
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinomaRead full original descriptionShow less
A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
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.