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| Name | Class |
|---|---|
| King's College London | OTHER |
'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation
Stage I: To evaluate the safety of administering TR002 to liver transplant recipients.
Stage II: To evaluate the efficacy of TR002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Regulatory T cell therapy | Experimental | Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous regulatory T cell product | Drug | Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of dose limiting toxicities (DLTs) | rate of adverse events qualifying as dose limiting toxicities | 1 month after IMP administration |
| Graft Loss | Rate of cellular rejection | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunosuppressive doses | total dose of immunosuppressive medication administered | 24 months |
| Prevention of acute and chronic rejection | incidence of rejection episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological biomarkers | immune monitoring analysis of blood samples investigating the effect of TR002 on blood cell immunophenotype | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanna Lombardi, PhD | King's College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings College Hospital | London | United Kingdom |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| 24 months |
| Acute and Chronic Toxicity | incidence of immunological reactions, biochemical disturbances | 24 months |
| Liver histology | liver biopsy analysis | 12 months |
| Rate of successful immunosuppressive drug withdrawal | total dose of immunosuppressive medication administered | 24 months |