NCT06617000 A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
| NCT ID | NCT06617000 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | SCG Cell Therapy Pte. Ltd. |
| Condition | HCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2022-10-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 38 participants in total. It began in 2022-10-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06617000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying HCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06617000 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06617000 currently recruiting?
Yes, NCT06617000 is actively recruiting participants. Contact the research team at clinicaltrials@scgcell.com for enrollment information.
Where is the NCT06617000 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China, Zhengzhou, China, Changchun, China and 3 additional locations.
Who is sponsoring the NCT06617000 clinical trial?
NCT06617000 is sponsored by SCG Cell Therapy Pte. Ltd.. The trial plans to enroll 38 participants.