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".
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
induced T cell with suppressive function
Juntendo University Hospital
Bunkyoku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, Japan
Kyoto University Hospital
Kyoto, Japan
Achievement of operational tolerance
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
Time frame: immunosuppressive drug cessation was maintained for at least 12 months
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Nagasaki University Hospital
Nagasaki, Japan