Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shenzhen Zhongke Qiyuan Biotechnology Co., Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QY-1-T | Experimental | Each patient will undergo a core study of approximately 1 year after enrollment: including screening period, apheresis, first treatment cycle (induction phase), observation period, second treatment cycle (maintenance phase), and routine follow-up period. The first treatment cycle (induction period): It is planned to use 4 induction doses of 1×10^4 cells/Kg, 1×10^5 cells/Kg, 1×10^6 cells/Kg, 5×10^6 cells/Kg or 10×10^6 cells/Kg respectively on day 1 ( C1D1), day 8 (C1D8), day 15 (C1D15) and day 22 (C1D22) received stepped dosing of QY-1-T. A 30-day medical observation will be conducted after the first treatment cycle, followed by the second treatment cycle. Second treatment cycle: The dose is 5×10^6 cells/Kg or 10×10^6 cells/Kg. TCR-T was infused once a week, that is, QY-1-T administration was performed on day 1 (C2D1), day 8 (C2D8), day 15 (C2D15), and day 22 (C2D22). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QY-1-T | Drug | QY-1-T is a TCR-T drug targeting HBV-related HCC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT) | To assess the tolerability of QY-1-T and determine the maximum tolerated dose (MTD) | Up to 1 month after the last infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: antitumor activity of QY-1-T in subjects with HBV-related HCC | Tumor response assessment in accordance with mRECIST and iRECIST | Up to 1 year after the last infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: antiviral activity of QY-1-T | Changes in serum levels of hepatitis B surface antigen (HBsAg) before and after QY-1-T infusion | Up to 1 year after the last infusion |
| Efficacy: antiviral activity of QY-1-T |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Long, MD | Contact | +86 18017317460 | jiang.long@shgh.cn | |
| Qi Li, MD | Contact | +86 13818207333 | leeqi2001@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Long, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
Not provided
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Changes in serum levels of hepatitis B virus deoxyribonucleic acid (HBV-DNA) before and after QY-1-T infusion
| Up to 1 year after the last infusion |
| D008107 |
| Liver Diseases |