NCT05417932 A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
| NCT ID | NCT05417932 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | SCG Cell Therapy Pte. Ltd. |
| Condition | Hepatitis B Virus Related Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2022-10-26 |
| Primary Completion | 2025-09 |
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 46 participants in total. It began in 2022-10-26 with a primary completion date of 2025-09.
⚠ 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 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
Eligibility 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
Contact & Investigator
SCG Cell Therapeutics
STUDY DIRECTOR
SCG Cell Therapy Pte. Ltd.
Frequently Asked Questions
Who can join the NCT05417932 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hepatitis B Virus Related Hepatocellular Carcinoma. 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 NCT05417932 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 NCT05417932 currently recruiting?
Yes, NCT05417932 is actively recruiting participants. Contact the research team at clinicaltrials@scgcell.com for enrollment information.
Where is the NCT05417932 trial being conducted?
This trial is being conducted at New York, United States, New York, United States, Hong Kong, Hong Kong, Hong Kong, Hong Kong and 2 additional locations.
Who is sponsoring the NCT05417932 clinical trial?
NCT05417932 is sponsored by SCG Cell Therapy Pte. Ltd.. The principal investigator is SCG Cell Therapeutics at SCG Cell Therapy Pte. Ltd.. The trial plans to enroll 46 participants.
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