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.
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Juntendo University
- Enrollment
- 10
- Locations
- 5
- Primary Endpoint
- Achievement of operational tolerance
Study 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".
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
JB-101
induced T cell with suppressive function
Intervention: JB-101 (Biological)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Koichiro Uchida
Associate Professpr
Juntendo University