Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT05417932

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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