NCT05417932 · SCG Cell Therapy Pte. Ltd.
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
(TCR-T)
What this study is about
This Phase 1/ 2a study is a conducted at multiple hospitals study to evaluate the safety, tolerability and effectiveness of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
View original scientific description
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
Interventions
BIOLOGICAL
SCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Primary outcome measures
Safety and tolerability of SCG101
Time frame: Start of SCG101 infusion until 100 days post SCG101 infusion
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Tumor response of SCG101 (Phase 2)
Time frame: Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received at least 2 standard systemic therapies
- 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,
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2025 · Source of record for eligibility and locations