RecruitingPhase 1NCT06617000

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

Sponsor

SCG Cell Therapy Pte. Ltd.

Enrollment

38 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

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.

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