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| Name | Class |
|---|---|
| Guangzhou Lion TCR Co Ltd | UNKNOWN |
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This is a open-label study to evaluate the safety and efficacy of autologous T-cells transfected with messenger ribonucleic acid (mRNA) encoding Hepatitis-B virus (HBV) antigen specific T cell receptor (TCR) in combination with nucleos(t)ide analogues (NAs) in HBeAg-positive and negative chronic hepatitis B patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LioCyx-M (Autologous T-cells transfected with mRNA encoding HBV antigen specific TCR) | Experimental | Escalating doses of LioCyx-M from 5×10E05 to 50×10E06 cells/kg body weight (BW), administered every two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LioCyx-M | Biological | Each patient will receive LioCyx-M infusion every one or two weeks, while continuing their existing nucleos(t)ide analog treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessments of adverse events | To evaluate the safety of LioCyx-M | Start of treatment until 28 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HBeAg levels | To evaluate the anti-viral efficacy of LioCyx-M | Up to 1 year after last dose |
| Changes in HBeAb levels | To evaluate the anti-viral efficacy of LioCyx-M |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Up to 1 year after last dose |
| Changes in HBsAg levels | To evaluate the anti-viral efficacy of LioCyx-M | Up to 1 year after last dose |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |