Phase I/II Study to Evaluate the Safety and Efficacy of JB-101(Induced T Cell With Suppressing Functions), to Induce Operational Tolerance in Living Donor Liver Transplantation.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Living-donor Liver Transplantation
- Sponsor
- Juntendo University
- Enrollment
- 10
- Locations
- 5
- Primary Endpoint
- Achievement of operational tolerance
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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".
Investigators
Koichiro Uchida
Associate Professpr
Juntendo University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Achievement of operational tolerance
Time Frame: 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