NCT04950842

Induction of Transplant Tolerance in LDLT Via iTS

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.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Juntendo University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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".

Conditions

• Living-donor Liver Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	JB-101	induced T cell with suppressive function

Timeline

• Start date: 2020-12-15
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2021-07-06
• Last updated: 2024-03-28

Locations

5 sites across 1 country: Japan