Treatment of advanced liver cancer using QY-1-T immunotherapy

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

This study is testing a new immunotherapy called QY-1-T to see if it can help people with advanced liver cancer related to hepatitis B who haven't had success with other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Drugs / interventions: chemotherapy, immunotherapy, CAR-T
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06251115 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety and efficacy of QY-1-T, a TCR-T immunotherapy targeting HBV, in patients with advanced hepatocellular carcinoma (HCC) associated with hepatitis B virus. The study aims to enroll patients who have not responded to or are intolerant of previous treatments, focusing on those with advanced stages of liver cancer. By evaluating the response to QY-1-T, the study seeks to provide insights into a potential new treatment option for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced HBV-related hepatocellular carcinoma who have failed previous treatments.

Not a fit: Patients with early-stage liver cancer or those who are candidates for surgery or local therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new hope for patients with advanced liver cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies using TCR-T immunotherapy have shown promise in treating various cancers, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Subjects aged 18-75 years old (male or female)
2. The subject voluntarily participate and have the ability to sign the informed consent independently
3. Patient with advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology (BCLC stage B and C, or CNLC stage IIA/IIB and IIIA/IIIB). One of the following four conditions applies:a. Patients with advanced hepatocellular carcinoma (HCC) who are not candidates for surgery or local therapy and have previously failed or become intolerable after at least second-line or higher standardized systemic therapy (including but not limited to targeted therapy, immunotherapy, or chemotherapy) and whose disease progression or intolerance has been determined by imaging examination during or after treatment, Or patients whom the investigator believes could benefit. b. HCC patients with clinically confirmed recurrence or progression after local treatment, and the interval between treatment and enrollment is at least 4 weeks. c. HCC recurrence after resection progresses or is not tolerated by systemic therapy or TACE/HAIC or radiofrequency ablation, and the interval between treatment and entrainment is at least 4 weeks. d. Recurrence of liver cancer after liver transplantation progresses or is not tolerated after systemic therapy or TACE/HAIC or radiofrequency ablation, and the interval between treatment and entrainment is at least 4 weeks
4. Prior systemic therapy should be discontinued for at least 2 weeks prior to enrollment
5. The expected survival time is more than 6 months
6. The subject has at least one tumor lesion that can be measured according to RECIST1.1
7. Hepatitis B virus surface antigen (HBsAg) positive or previous positive history
8. The HLA typing of peripheral blood was HLA-A\*11:01
9. Non-cirrhosis or compensatory cirrhosis Child-Pugh \< 7 score
10. ECOG scoring standard ≤1
11. Blood routine and blood biochemical indicators: a. white blood cells ≥3×10\^9/L. b. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× upper limit of normal (ULN). c. Serum total bilirubin ≤2×ULN. d.eGFR≥60ml /min. e. Hemoglobin \> 90g/L. f. Platelet count ≥50×10\^9/L. g. Creatinine ≤1.5×ULN. h. International standardized ratio INR≤1.5 or activated partial thrombin time (APTT) extended within 10s.
12. Female subjects of childbearing age, whose serum pregnancy tests must be negative, and all subjects must agree to take effective contraceptive measures during the test
13. Subject agrees to abstain from alcohol during the study
14. The subject is willing and able to follow all treatment procedures and protocols

Exclusion Criteria:

1. The presence of a secondary primary malignancy, except in the following cases: a. Non-melanoma treated by excision, such as basal cell skin cancer. b. curable carcinoma in situ, such as cervical, bladder or breast cancer
2. Liver tumor load exceeds 70%
3. Co-transplanters
4. Main portal vein cancer thrombus
5. Moderate to severe ascites
6. Human immunodeficiency virus (HIV) 1 or 2 positive or acquired immunodeficiency syndrome (AIDS) history, treponema pallidum antibody positive
7. Decompensated cirrhosis Child-Pugh B or C (7-15 points)
8. Clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, hereditary or acquired bleeding and thrombosis tendency (such as hemophilia, coagulation disorder, thrombocytopenia, hypersplenism, etc.) within 2 weeks prior to the study, and more serious arteriovenous thrombosis events occurring within the previous 6 months,Such as cerebrovascular diseases (including cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
9. Have high blood pressure that cannot be effectively controlled, i.e. systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 110 mmHg after antihypertensive treatment
10. Serum HBV DNA≥1000 IU/ml during screening (HBV positive for transplant donors of primary liver cancer patients), antiviral treatment can be performed according to the actual situation before admission
11. HCV RNA positive
12. Prior cell therapy, such as but not limited to NK, CIK, DC, CTL, stem cell therapy
13. Concurrent treatment with other anti-tumor therapies, including cytotoxic chemotherapy, hormone therapy and immunotherapy
14. Use of immune checkpoint inhibitors within 1 month
15. Patient with Grade III or IV cardiac dysfunction, arrhythmias that cannot be controlled by drugs or QTc interval \> 450ms for men and \> 470ms for women according to the NYHA grading criteria
16. Any other medical conditions that may increase subjects' risk or interfere with study results
17. Has any condition that interferes with drug administration and study sample collection
18. Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders
19. Participate in other drug clinical studies within 4 weeks before screening
20. Pregnant or lactating women
21. Failure to follow or cooperate with relevant treatment procedures and protocols during the study period

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jiang Long, MD — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Jiang Long, MD

Conditions: Liver Cancer, TCR- T, HBV-HCC, Immunotherapy, Liver cancer