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

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called SCG101 for people with liver cancer (hepatocellular carcinoma) that is related to chronic hepatitis B virus infection. SCG101 uses the patient's own modified immune cells to target and attack cancer cells that carry the hepatitis B virus. **You may be eligible if...** - You have been diagnosed with liver cancer confirmed by biopsy or imaging - Your liver cancer is related to hepatitis B virus (HBsAg positive) - You have already received at least 2 prior systemic treatments that have not worked - You have a specific immune system marker (HLA-A*02) - Your liver function and overall health are adequate **You may NOT be eligible if...** - You have cancer that has spread widely or your liver function is severely impaired - You have active hepatitis C or HIV - You have uncontrolled fluid in the abdomen or bleeding from the digestive tract - You have had a prior organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSCG101

Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.


Locations(6)

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

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NCT05417932


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