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Clinical Trials in China / NCT06617000
Recruiting Phase 1

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

NCT06617000 · tracked via the Priya Life Science China tracker
Sponsor
SCG Cell Therapy Pte. Ltd.
Phase
Phase 1
Started
2022-10-25
Last updated
2024-09-27

Condition(s) studied

HCCHepatitis B Virus Related Hepatocellular CarcinomaHepatocellular Carcinoma

Investigational drug(s) / intervention(s)

SCG101

SCG101: Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Beijing Beijing Beijing Municipality Recruiting
Guangzhou Guangzhou Guangdong Recruiting
Zhengzhou Zhengzhou Henan Recruiting
Changchun Changchun Jilin Recruiting
Shenyang Shenyang Liaoning Recruiting
Ji'nan Ji'nan Shandong Recruiting
Shanghai Shanghai Shanghai Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06617000 on ClinicalTrials.gov ↗ ← All trials in China