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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.
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".
Age
20 - 80 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 15, 2020
Primary Completion Date
February 28, 2026
Completion Date
February 28, 2026
Last Updated
March 28, 2024
10
ACTUAL participants
JB-101
BIOLOGICAL
Lead Sponsor
Juntendo University
Collaborators
Data Source & Attribution
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