'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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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.
Kings College Hospital
London, United Kingdom
Rate of dose limiting toxicities (DLTs)
rate of adverse events qualifying as dose limiting toxicities
Time frame: 1 month after IMP administration
Graft Loss
Rate of cellular rejection
Time frame: 24 months
Immunosuppressive doses
total dose of immunosuppressive medication administered
Time frame: 24 months
Prevention of acute and chronic rejection
incidence of rejection episodes
Time frame: 24 months
Acute and Chronic Toxicity
incidence of immunological reactions, biochemical disturbances
Time frame: 24 months
Liver histology
liver biopsy analysis
Time frame: 12 months
Rate of successful immunosuppressive drug withdrawal
total dose of immunosuppressive medication administered
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.