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RECRUITINGPhase 1INTERVENTIONAL

A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

A Phase 1, 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 is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-confirmed) Hepatocellular carcinoma (HCC) - Subjects with HCC who have received standard systemic therapies - HLA-A \*02 - BCLC stage B or C - Child-pugh score ≤ 7 ol - Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml - Have at least one measurable leasion at baseline as per mRECIST and iRECIST - Life expectancy of 3 months or greater - The organ function is in good condition. Who Should NOT Join This Trial: - Subjects with history of another primary cancer within 5 years - Central nervous system metastasis and clinically significant central nervous system disease - Previous or current coexistence of hepatic encephalopathy - Currently present with symptomatic third space fluid accumulation - Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment) - Known history of neurological or mental disorder, including epilepsy or dementia - Suffering from active autoimmune conditions (where your immune system attacks your own body)s, or other significant ongoing immune rejection based on pathology and clinical diagnosis - 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 - Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection - Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine) - 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
Inclusion Criteria: * Histologically or cytologically confirmed Hepatocellular carcinoma (HCC) * Subjects with HCC who have received standard systemic therapies * HLA-A \*02 * BCLC stage B or C * Child-pugh score ≤ 7 ol * Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml * Have at least one measurable leasion at baseline as per mRECIST and iRECIST * Life expectancy of 3 months or greater * The organ function is in good condition. Exclusion Criteria: * Subjects with history of another primary cancer within 5 years * Central nervous system metastasis and clinically significant central nervous system disease * Previous or current coexistence of hepatic encephalopathy * Currently present with symptomatic third space fluid accumulation * Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment) * Known history of neurological or mental disorder, including epilepsy or dementia * Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis * 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 * Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection * Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine) * 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 (7)

Beijing
Beijing, Beijing Municipality, China
Guangzhou
Guangzhou, Guangdong, China
Zhengzhou
Zhengzhou, Henan, China
Changchun
Changchun, Jilin, China
Shenyang
Shenyang, Liaoning, China
Ji'nan
Ji'nan, Shandong, China
Shanghai
Shanghai, Shanghai Municipality, China