Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Main Who May Qualify: - diagnosed by tissue sample (biopsy-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 willing to sign a consent form form - Ability to comply with all the study procedures Main Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s 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 weakened immune system virus (HIV) 1 or 2 or known acquired weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

SCG101

Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

Locations (6)

New York
New York, New York, United States
New York
New York, New York, United States
Hong Kong is.
Hong Kong, Hong Kong
Hong Kong NT
Hong Kong, Hong Kong
Singapore
Singapore, Singapore
Singapore
Singapore, Singapore