Induction of Transplant Tolerance in LDLT Via iTS

Sponsor

Juntendo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04950842

Collaborator

Junten Bio Co., Ltd. (Industry)

Enrollment

Locations

Arm

50.5

Anticipated Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Living-donor Liver Transplantation	Biological: JB-101	Phase 1/Phase 2

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

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Dec 15, 2020

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Feb 28, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JB-101 induced T cell with suppressive function	Biological: JB-101 induced T cell with suppressive function

Arm

Intervention/Treatment

Experimental: JB-101

induced T cell with suppressive function

Biological: JB-101

induced T cell with suppressive function

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Tokyo Women's Medical University Hospital	Shinjuku	Tokyo	Japan
2	Hiroshima University Hospital	Hiroshima		Japan
3	Nagasaki University Hospital	Nagasaki		Japan

Sponsors and Collaborators

Juntendo University
Junten Bio Co., Ltd.

Investigators

Study Chair: Koichiro Uchida, M.D.,Ph.D., Juntendo University Advanced Research Institute for Health Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Koichiro Uchida, Associate Professpr, Juntendo University

ClinicalTrials.gov Identifier:

NCT04950842

Other Study ID Numbers:

jRCT2073200067

First Posted:

Jul 6, 2021

Last Update Posted:

Sep 17, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Koichiro Uchida, Associate Professpr, Juntendo University

living-donor liver transplantation

immunotolerance

operational tolerance

cell therapy

Study Results

No Results Posted as of Sep 17, 2021