Induction of Transplant Tolerance in LDLT Via iTS
- Conditions
- Living-donor Liver Transplantation
- Interventions
- Biological: JB-101
- Registration Number
- NCT04950842
- Lead Sponsor
- Juntendo University
- Brief Summary
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.
- Detailed Description
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".
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JB-101 JB-101 induced T cell with suppressive function
- Primary Outcome Measures
Name Time Method Achievement of operational tolerance immunosuppressive drug cessation was maintained for at least 12 months 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
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
Nagasaki University Hospital
🇯🇵Nagasaki, Japan