RecruitingPhase 1Phase 2NCT05417932
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Sponsor
SCG Cell Therapy Pte. Ltd.
Enrollment
46 participants
Start Date
Oct 26, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria10
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received at least 2 standard systemic therapies
- HLA-A \*02
- BCLC stage B or C
- Child-pugh score ≤ 7
- Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
- Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
- Life expectancy of 3 months or greater
- Ability to provide informed consent form
- Ability to comply with all the study procedures
Exclusion Criteria9
- Subjects with history of another primary cancer
- Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
- Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
- Known history of neurological or mental disorder, including epilepsy or dementia
- Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- 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, CAR T/TCR T cell therapy
- Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Interventions
BIOLOGICALSCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05417932
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