RecruitingPhase 1NCT06617000

A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma


Sponsor

SCG Cell Therapy Pte. Ltd.

Enrollment

38 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing SCG101, a type of engineered T-cell therapy (called TCR-T cell therapy) that targets the hepatitis B virus, in patients with liver cancer (hepatocellular carcinoma) that is related to hepatitis B virus infection. The immune cells are modified to recognize and attack cancer cells that carry the virus. **You may be eligible if...** - You have been confirmed to have hepatitis B virus-related hepatocellular carcinoma (HCC) - You have already received standard systemic treatments for liver cancer - You carry a specific immune marker (HLA-A*02) - Your cancer is classified as Barcelona Clinic Liver Cancer stage B or C - Your liver is functioning reasonably well (Child-Pugh score ≤ 7) - You test positive for the hepatitis B surface antigen (HBsAg) but negative for HBeAg - You have at least one measurable tumor and a life expectancy of at least 3 months **You may NOT be eligible if...** - You have another primary cancer diagnosed within the last 5 years - You have brain metastases or active liver failure (hepatic encephalopathy) - You have severe fluid buildup in the abdomen 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(7)

Beijing

Beijing, Beijing Municipality, China

Guangzhou

Guangzhou, Guangdong, China

Zhengzhou

Zhengzhou, Henan, China

Changchun

Changchun, Jilin, China

Shenyang

Shenyang, Liaoning, China

Ji'nan

Ji'nan, Shandong, China

Shanghai

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06617000


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