Treatment of Hepatitis B Virus-Related Liver Cancer with SCG101
A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
This study is testing a new treatment called SCG101 to see if it can safely help people with liver cancer caused by hepatitis B.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | SCG Cell Therapy Pte. Ltd. Industry-sponsored |
| Drugs / interventions | CAR T, chemotherapy, immunotherapy, cyclophosphamide, fludarabine |
| Locations | 6 sites (New York, New York and 5 other locations) |
| Trial ID | NCT05417932 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2a clinical trial evaluates the safety, tolerability, and efficacy of SCG101 in patients with hepatitis B virus-related hepatocellular carcinoma (HCC). The study is divided into two phases: Phase 1 involves dose escalation with cohorts of 3-6 subjects receiving increasing doses of SCG101 to determine the recommended phase 2 dose based on safety and antitumor activity. Phase 2a will further assess the safety and efficacy of SCG101 in a larger group of subjects. The trial aims to provide insights into a potential new treatment option for patients with advanced liver cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed hepatocellular carcinoma who have received at least two standard systemic therapies and meet specific eligibility criteria.
Not a fit: Patients with untreated or active central nervous system metastasis or those with a history of another primary cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from hepatitis B virus-related liver cancer.
How similar studies have performed: Other studies have shown promise in targeting hepatocellular carcinoma with novel therapies, but the specific approach of SCG101 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 5 other locations
- New York — New York, New York, United States (Recruiting)
- New York — New York, New York, United States (Recruiting)
- Hong Kong is. — Hong Kong, Hong Kong (Not_yet_recruiting)
- Hong Kong NT — Hong Kong, Hong Kong (Recruiting)
- Singapore — Singapore, Singapore (Recruiting)
- Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: SCG Cell Therapy
- Email: clinicaltrials@scgcell.com
- Phone: (65) 68297180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.