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| Name | Class |
|---|---|
| Lion TCR Pte. Ltd. | INDUSTRY |
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This is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCR-Redirected T Cells | Experimental | HBV antigen specific TCR redirected T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCR redirected T cells | Biological | HBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10^4 - 5x10^6 TCR redirected T cells by IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation based in Incidences of adverse events/serious adverse events | Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported. | Up to 1 month after the last infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Tumour assessment will be according to mRECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST v1.1 from baseline. | Start of Treatment until first documented CR or PR, assessed up to 56 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first) |
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Inclusion Criteria:
Expression of the specific human leukocyte antigen (HLA) class I profile
Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg)
BCLC stage C
At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication
Laboratory criteria:
Sexually active subjects must be willing to use an acceptable method of contraception
Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Shi | Contact | 86-10-63879735 | shiming302@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Fusheng Wang, MD | Beijing 302 Hospital of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing 302 Hospital of China | Recruiting | Beijing | Beijing Municipality | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34850325 | Derived | Meng F, Zhao J, Tan AT, Hu W, Wang SY, Jin J, Wu J, Li Y, Shi L, Fu JL, Yu S, Shen Y, Liu L, Luan J, Shi M, Xie Y, Zhou CB, Wong RW, Lu-En W, Koh S, Bertoletti A, Wang T, Zhang JY, Wang FS. Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial. Hepatol Int. 2021 Dec;15(6):1402-1412. doi: 10.1007/s12072-021-10250-2. Epub 2021 Nov 30. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Overall survival rate | Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years. | Up to 5 years from the last infusion |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |