A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
NCT ID: NCT05417932
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2022-10-26
2025-10-31
Brief Summary
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Detailed Description
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In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SCG101
This is a single arm study.
Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.
SCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Interventions
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SCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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SCG Cell Therapy Pte. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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SCG Cell Therapeutics
Role: STUDY_DIRECTOR
SCG Cell Therapy Pte. Ltd.
Locations
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New York
New York, New York, United States
New York
New York, New York, United States
Hong Kong is.
Hong Kong, , Hong Kong
Hong Kong NT
Hong Kong, , Hong Kong
Singapore
Singapore, , Singapore
Singapore
Singapore, , Singapore
Countries
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Central Contacts
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Other Identifiers
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SCG101-UR-103
Identifier Type: -
Identifier Source: org_study_id
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