Phase
Condition
Carcinoma
Liver Disorders
Digestive System Neoplasms
Treatment
SCG101
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 mustbe ≤ 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
Exclusion Criteria:
Subjects with history of another primary cancer within 5 years
Central nervous system metastasis and clinically significant central nervous systemdisease
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., arterialhypertension 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 immunerejection 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 IgMantibody; or there is current evidence indicating the presence of HEV infection
Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamideand fludarabine)
Any condition which, in the investigator's opinion, makes the subject unsuitable fortrial participation
Study Design
Connect with a study center
Beijing
Beijing, Beijing 100020
ChinaActive - Recruiting
Guangzhou
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
Zhengzhou
Zhengzhou, Henan 450003
ChinaActive - Recruiting
Changchun
Chang chun, Jilin 130000
ChinaActive - Recruiting
Shenyang
Shenyang, Liaoning 110000
ChinaActive - Recruiting
Ji'nan
Ji'nan, Shandong 250000
ChinaActive - Recruiting
Shanghai
Shanghai, Shanghai 200000
ChinaActive - Recruiting
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