Actively Recruiting
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Led by SCG Cell Therapy Pte. Ltd. · Updated on 2025-02-18
46
Participants Needed
6
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
CONDITIONS
Official Title
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received at least 2 standard systemic therapies
- HLA-A *02 positive
- BCLC stage B or C
- Child-Pugh score of 7 or less
- Serum HBeAg negative, serum or tumor tissue HBsAg positive, and serum HBV-DNA at least 2000 IU/ml
- At least one measurable lesion at baseline per mRECIST and RECIST v1.1 criteria
- Life expectancy of 3 months or greater
- Ability to provide informed consent
- Ability to comply with all study procedures
You will not qualify if you...
- History of another primary cancer
- Untreated or active central nervous system or leptomeningeal metastasis, history of hepatic encephalopathy, or other significant CNS diseases
- Autoimmune diseases requiring immunosuppressive therapy (except topical medications) or significant persistent immune rejection
- Known neurological or mental disorders including epilepsy or dementia
- Known positive HIV 1 or 2 or AIDS
- Prior exposure to any cell therapy such as NK cells, CIK cells, dendritic cells, cytotoxic T lymphocytes, stem cell therapy, CAR T or TCR T cell therapy
- Allergy to immunotherapy drugs or lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- Inability to undergo triphasic liver CT or MRI due to allergy or contraindication to contrast agents
- Any condition making the subject unsuitable for trial participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
New York
New York, New York, United States, 10029
Actively Recruiting
2
New York
New York, New York, United States, 10065
Actively Recruiting
3
Hong Kong is.
Hong Kong, Hong Kong
Not Yet Recruiting
4
Hong Kong NT
Hong Kong, Hong Kong
Actively Recruiting
5
Singapore
Singapore, Singapore, 169610
Actively Recruiting
6
Singapore
Singapore, Singapore, 228510
Actively Recruiting
Research Team
S
SCG Cell Therapy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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