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This is a single center, single arm, open label study to assess the safety, tolerability and effectiveness of the autologous HBV specific T cell receptor (HBV-TCR) redirected T cells in patients with chronic hepatitis B with ongoing with nucleos(t)ide analogue (NUC) treatment. This study will be conducted sequentially starting with Stage-1, followed by Stage-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBV-TCR T cell infusion | Experimental | Autologous HBV specific TCR redirected T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCR-T | Biological | Stage-1: Patients will receive three biweekly HBV-TCR T cell infusions at escalating doses, ranging from 1 x 10^5 cells/kg to 5 x 10^6 cells/kg bodyweight (by IV infusion). Patients are to remain on existing HBV NUC treatment. Stage-2: Patients will receive three biweekly HBV-TCR T cell infusions at maximum dose as determined in Stage-1 study. Patients are to remain on existing HBV NUC treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation of HBV-TCR T cell treatment | Incidence of adverse events/serious adverse events | Start of Treatment until 28 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the capability of HBV-TCR T cell treatment to lower the levels of serum HBsAg | This is based on quantitative changes of HBsAg levels from baseline | Start of treatment until 12 months post treatment follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fu-Sheng Wang, MD | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Beijing | 100039 | 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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|
| 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 |