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A Study of SCG101 for Hepatitis B-Related Liver Cancer

This study is testing a treatment called SCG101 for people with liver cancer (hepatocellular carcinoma) linked to the hepatitis B virus. SCG101 is an immunotherapy that uses your own immune cells, specifically T cells, to fight the cancer. You might be able to join if you are 18-70 years old, have liver cancer confirmed by a biopsy, and have already tried at least two standard treatments. You also need to have specific genetic markers (HLA-A *02) and certain hepatitis B virus levels. The study will look at how safe SCG101 is and how well it shrinks tumors. The current status of the study is unclear, and it plans to enroll 46 participants.

Study design
This is an interventional study with two parts: a Phase 1 dose escalation to find the best dose, followed by a Phase 2a to further evaluate safety and effectiveness. It is a multicenter study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your tumor response will be monitored until a complete or partial response, disease progression, or for long-term survival for up to 15 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05417932

A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Recruiting
PHASE1Ages 18–70InterventionalTreatment
SCG Cell Therapy Pte. Ltd.
~46 participants
Updated 2025-02-18 on ClinicalTrials.gov
What's tested:SCG101

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of SCG101
Measured over Start of SCG101 infusion until 100 days post SCG101 infusion
+1 more outcome measured

Conditions

Hepatitis B Virus Related Hepatocellular Carcinoma
Hepatocellular Carcinoma Recurrent

Explore related trials

Hepatocellular CarcinomaHBV-DNAHepatitis B Virus HBsAg Surface Protein AntigenHLA-A Gene

NCT05417932

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hong Kong is.

    Hong Kong, Hong Kongno site contact published

    Not yet recruiting

  • Hong Kong NT

    Hong Kong, Hong Kongno site contact published

    Recruiting

  • New York

    New York, New Yorkno site contact published

    Recruiting

  • New York

    New York, New Yorkno site contact published

    Recruiting

  • Singapore

    Singapore, Singaporeno site contact published

    Recruiting

  • Singapore

    Singapore, Singaporeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • SCG Cell Therapeutics · STUDY_DIRECTOR · SCG Cell Therapy Pte. Ltd.

Who to contact

SCG Cell Therapy
[email protected]
(65) 68297180
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Safety and tolerability of SCG101Start 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)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