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New treatment option for Hepatitis B Virus Related Hepatocellular Carcinoma
Official title A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT05417932
What this study is testing
What is SCG101?
SCG101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatitis b virus related hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Main
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- people with HCC who have received at least 2 standard systemic therapies
- HLA-A \ 02
- BCLC stage B or C
You likely can't join if
- people 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...
- Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or people 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)...
See the full eligibility criteria
- Main
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- people 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
- people 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 people 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 people 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Hong Kong, Hong Kong
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Hong Kong, Hong Kong; Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.