Tests SCG101 in adults with hepatitis B-related liver cancer
Tests SCG101, a biological treatment, in adults with liver cancer linked to hepatitis B.
Key facts
- Who runs it
- SCG Cell Therapy Pte. Ltd.
- Where
- Singapore, SingaporeSee the siteAlso in 2 other countries, 3 sites
- Trial code
- Registry title
- A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 46 people, planned
- Started
- 26 Oct 2022
- Planned end
- Oct 2025
- Type of study
- Interventional
- Treatments tested
- SCG101
- Record updated
- 18 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with hepatitis B virus-related liver cancer (hepatocellular carcinoma) who have already had at least 2 standard systemic treatments.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Hepatocellular carcinoma confirmed by tissue or cell tests. BCLC stage B or C. Child-Pugh score of 7 or lower. At least one measurable tumour. Life expectancy of 3 months or more.
- Earlier treatment
- Must have had at least 2 standard systemic therapies. Cannot have had any earlier cell therapy, such as NK cells, CIK cells, dendritic cells, CTL, stem cell therapy or CAR T/TCR T cell therapy.
- Biomarker or test result
- HLA-A *02. Serum HBeAg negative. HBsAg positive in serum or tumour tissue. Serum HBV-DNA of 2 × 1000 IU/ml.
Main reasons for not taking part
- History of another primary cancer
- Active or untreated cancer spread to the brain or its linings, or history of hepatic encephalopathy
- Autoimmune disease needing immunosuppressive treatment
- Known HIV or AIDS
- Allergy to immunotherapy drugs or to cyclophosphamide and fludarabine
The registry criteria, word for word
Show all 20 criteriaShow less
Other criteria
- 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
Check if you might fit
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?
Where in Singapore
Also in 2 other countries, 3 sites
- SingaporeSingapore, SingaporeContact: SCG Cell TherapyTaking people
About the trial
What the trial wants to find out
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
The group in the trial
- SCG101Treatment being tested
This is a single arm study. Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
- Plain-language title
- Tests SCG101 in adults with hepatitis B-related liver cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05417932, who can take part
- Record updated
- 18 February 2025