For Healthcare Professionals

A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Main Inclusion Criteria:

  1. Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
  2. Subjects with HCC who have received at least 2 standard systemic therapies
  3. HLA-A *02
  4. BCLC stage B or C
  5. Child-pugh score ≤ 7
  6. Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
  7. Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
  8. Life expectancy of 3 months or greater
  9. Ability to provide informed consent form
  10. Ability to comply with all the study procedures

EXCLUSION CRITERIA

Main Exclusion Criteria:

  1. Subjects with history of another primary cancer
  2. Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
  3. Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
  4. Known history of neurological or mental disorder, including epilepsy or dementia
  5. Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
  6. 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
  7. Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
  8. 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
  9. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (65) 68297180Email iconEmail Study Center

Study Details


Contition

Hepatitis B Virus Related Hepatocellular Carcinoma,Hepatocellular Carcinoma Recurrent

Age

18 - 70

Phase

PHASE1/PHASE2

Participants Needed

46

Est. Completion Date

Oct 31, 2025

Treatment Type

INTERVENTIONAL


Sponsor

SCG Cell Therapy Pte. Ltd.

ClinicalTrials.gov NCT Identifier

NCT05417932

Study Number

SCG101-UR-103

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