Japan research institute is undertaking a Phase I/II Study to Evaluate the Safety and Efficacy of JB-101(Induced Regulatory T Cell), to Induce Operational Tolerance in Living Donor Liver Transplantation study.
The purpose of this clinical trial is to examine the immunotolerance-inducing ability (effectiveness) of induced inhibitory T cells JB-101 in patients with living-donor liver transplantation using "whether or not operational tolerance is achieved" as an index. And the safety of JB-101 will be evaluated.
This trial is a phase I / II, open-label, single-arm, multicenter clinical trial of JB-101, an inducible inhibitory T cell, in patients with end-stage liver failure who undergo living-donor liver transplantation. The primary endpoint of efficacy is withdrawal from immunosuppressant by 78 weeks (up to 91 weeks) after liver transplantation, and then "whether or not operational tolerance is achieved".
The clinical trial started in December 15, 2020 and will continue throughout February 28, 2025.
Achievement of operational tolerance will be primary outcome measure. Achievement of "Operational Tolerance" defined as no biopsy proven rejection diagnosed by Banff criteria for more than 52 weeks after withdrawal of immunosuppressive drugs post transplant.
Inclusion Criteria： Patients with end-stage liver failure undergoing living-donor liver transplantation. Subjects who are healthy physically and psychologically and willing to donate organs voluntarily. Relative within the second degree of relationship or partner. (Acceptable degree conforms eligibility criteria of the institution.) Exclusion Criteria： Patients who have clinical findings of active infection. Patients with advanced heart disease, fulminant hepatitis in liver failure, renal disease, malignant tumors and complications of immunodeficiency.
The contacts and locations are the Tokyo Women's Medical University Hospital, Shinjuku, Tokyo, Japan; Hiroshima University Hospital, Hiroshima, Japan; Nagasaki University Hospital, Nagasaki, Japan. For more details:https://ichgcp.net/clinical-trials-registry/NCT04950842.