A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Recruiting now · Phase 1
Conditions studied: HCC, Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma
In brief
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
Key facts
- Study ID
- NCT06617000
- Run by
- SCG Cell Therapy Pte. Ltd.
- People needed
- 38
- Starts
- 2022-10-25
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-09-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Beijing — Beijing, Beijing Municipality, China (enrolling)
- Guangzhou — Guangzhou, Guangdong, China (enrolling)
- Zhengzhou — Zhengzhou, Henan, China (enrolling)
- Changchun — Changchun, Jilin, China (enrolling)
- Shenyang — Shenyang, Liaoning, China (enrolling)
- Ji'nan — Ji'nan, Shandong, China (enrolling)
- Shanghai — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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