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| Name | Class |
|---|---|
| Beijing GoBroad Hospital | OTHER |
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This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LioCyx-M | Experimental | LioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10^6 cells/kg body weight (BW). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LioCyx-M, HBV antigen-specific TCR-redirected T cells | Drug | Via intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessments of adverse events/serious adverse events | To evaluate the safety of LioCyx-M | Start of treatment until 28 days post last dose |
| Objective Response Rate (ORR) | To evaluate the anti-tumor efficacy of LioCyx-M | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | To evaluate the anti-tumor efficacy of LioCyx-M | Up to 2 years |
| Progression Free Survival (PFS) | To evaluate the anti-tumor efficacy of LioCyx-M |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Zhe | Contact | +86 15902091916 | zhe.wang@liontcr.com |
| Name | Affiliation | Role |
|---|---|---|
| Tina Wang | Lion TCR Pte. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaobo Boren Hospital | Recruiting | Beijing | China |
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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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| Up to 2 years |
| Overall Survival (OS) | To evaluate the anti-tumor efficacy of LioCyx-M | Up to 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |