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

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04950842

Enrollment

Registered

2021-07-06

Start date

2020-12-15

Completion date

2026-02-28

Last updated

2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Living-donor Liver Transplantation

Keywords

living-donor liver transplantation, immunotolerance, operational tolerance, cell therapy

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.

Interventions

BIOLOGICALJB-101

induced T cell with suppressive function

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026