A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Recruiting · NCT06617000 · Interventional (participants receive a specific treatment) · Lead sponsor: SCG Cell Therapy Pte. Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
SCG101
What this trial is about
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
7 locations listed.
- 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