Treatment of Hepatitis B Virus-Related Liver Cancer with SCG101

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2a clinical trial evaluates the safety, tolerability, and efficacy of SCG101 in patients with hepatitis B virus-related hepatocellular carcinoma (HCC). The study is divided into two phases: Phase 1 involves dose escalation with cohorts of 3-6 subjects receiving increasing doses of SCG101 to determine the recommended phase 2 dose based on safety and antitumor activity. Phase 2a will further assess the safety and efficacy of SCG101 in a larger group of subjects. The trial aims to provide insights into a potential new treatment option for patients with advanced liver cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• New York
  New York, New York, United States Recruiting
• New York
  New York, New York, United States Recruiting
• Hong Kong NT
  Hong Kong, Hong Kong Recruiting
• Singapore
  Singapore, Singapore Recruiting
• Singapore
  Singapore, Singapore Recruiting
• Hong Kong is.
  Hong Kong, Hong Kong Not yet recruiting

Study contacts

• Study coordinator: SCG Cell Therapy
• Email: clinicaltrials@scgcell.com
• Phone: (65) 68297180

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.