Treatment of Hepatocellular Carcinoma with SCG101 TCR-T Cell Therapy
A Phase 1, 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 for people with liver cancer related to Hepatitis B who haven't had success with other therapies to see if it helps them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | SCG Cell Therapy Pte. Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, cyclophosphamide, fludarabine |
| Locations | 7 sites (Beijing, Beijing Municipality and 6 other locations) |
| Trial ID | NCT06617000 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical study evaluates the safety, tolerability, and efficacy of SCG101 monotherapy in patients diagnosed with Hepatitis B Virus-related Hepatocellular Carcinoma (HBV-HCC). The study focuses on patients who have previously undergone standard systemic therapies and meet specific eligibility criteria, including certain HLA types and disease stages. Participants will receive SCG101 treatment, and their responses will be monitored to assess the potential benefits of this innovative therapy.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed HCC who have received prior systemic therapies and meet specific health criteria.
Not a fit: Patients with a history of other primary cancers, central nervous system metastasis, or poorly controlled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HBV-related HCC who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar TCR-T cell therapies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed Hepatocellular carcinoma (HCC) * Subjects with HCC who have received standard systemic therapies * HLA-A \*02 * BCLC stage B or C * Child-pugh score ≤ 7 ol * Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml * Have at least one measurable leasion at baseline as per mRECIST and iRECIST * Life expectancy of 3 months or greater * The organ function is in good condition. Exclusion Criteria: * Subjects with history of another primary cancer within 5 years * Central nervous system metastasis and clinically significant central nervous system disease * Previous or current coexistence of hepatic encephalopathy * Currently present with symptomatic third space fluid accumulation * Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment) * Known history of neurological or mental disorder, including epilepsy or dementia * Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis * 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 * Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection * Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine) * Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Where this trial is running
Beijing, Beijing Municipality and 6 other locations
- Beijing — Beijing, Beijing Municipality, China (Recruiting)
- Guangzhou — Guangzhou, Guangdong, China (Recruiting)
- Zhengzhou — Zhengzhou, Henan, China (Recruiting)
- Changchun — Changchun, Jilin, China (Recruiting)
- Shenyang — Shenyang, Liaoning, China (Recruiting)
- Ji'nan — Ji'nan, Shandong, China (Recruiting)
- Shanghai — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: SCG Cell Therapy
- Email: clinicaltrials@scgcell.com
- Phone: 021-50339500
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.