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Induction of Transplant Tolerance in LDLT Via iTS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04950842
Recruitment Status : Active, not recruiting
First Posted : July 6, 2021
Last Update Posted : March 28, 2024
Sponsor:
Collaborator:
Junten Bio Co., Ltd.
Information provided by (Responsible Party):
Koichiro Uchida, Juntendo University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual 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 : December 15, 2020
Estimated Primary Completion Date : February 28, 2026
Estimated Study Completion Date : February 28, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: JB-101
induced T cell with suppressive function
 Biological: JB-101
induced T cell with suppressive function


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950842


Locations
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Japan
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
Sponsors and Collaborators
Juntendo University
Junten Bio Co., Ltd.
Investigators
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Study Chair: Koichiro Uchida, M.D.,Ph.D. Juntendo University Advanced Research Institute for Health Science
More Information
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Publications of Results:

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Responsible Party: Koichiro Uchida, Associate Professpr, Juntendo University
ClinicalTrials.gov Identifier: NCT04950842    
Other Study ID Numbers: jRCT2073200067
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Koichiro Uchida, Juntendo University:
living-donor liver transplantation
immunotolerance
operational tolerance
cell therapy