RecruitingNot ApplicableNCT06251115

Clinical Study on the Safety and Efficacy of QY-1-T in the Treatment of HBV-associated Advanced HCC

Clinical Study on the Safety and Efficacy of QY-1-T in the Treatment of HBV-associated Advanced Liver Cancer

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

9 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Cancer

Summary

The vast majority of liver cancers have an insidious onset and are often asymptomatic in the early stages, making early diagnosis difficult. Once diagnosed, most liver cancers have reached locally advanced stages or distant metastases, equivalent to Barcelona stage (BCLC) C-D. The tumors progress rapidly and there is a lack of effective treatments. The survival period of cancer patients is generally only 3-6 months. Cellular immunotherapy, including CAR-T and TCR-T, is considered a new hope for the treatment of cancer. The purpose of this study is to explore the safety of QY-1-T (a TCR-T targeting HBV) in the treatment of HBV-related liver cancer, and to preliminarily evaluate the efficacy of QY-1-T in patients with HBV-related advanced liver cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cell therapy called QY-1-T for people with advanced liver cancer (hepatocellular carcinoma, HCC) that is associated with hepatitis B virus (HBV) and has not responded to at least two prior standard treatments. The therapy uses the patient's own immune cells, which are modified to fight the cancer more effectively. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced liver cancer (HCC at BCLC stage B or C) - Your HCC is linked to hepatitis B infection - You have tried and failed at least two prior treatments (such as targeted therapy or immunotherapy) - You have not had liver transplantation **You may NOT be eligible if...** - You have not yet tried second-line or later treatment - You have active hepatitis B replication that cannot be controlled - You have serious heart, kidney, or liver function problems - You are pregnant or breastfeeding - You have active autoimmune disease or serious infection 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

DRUGQY-1-T

QY-1-T is a TCR-T drug targeting HBV-related HCC

Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06251115

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