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.
1 other identifier
interventional
10
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2020
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2020
CompletedFirst Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMarch 28, 2024
March 1, 2024
5.2 years
April 9, 2021
March 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Achievement of operational tolerance
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
immunosuppressive drug cessation was maintained for at least 12 months
Study Arms (1)
JB-101
EXPERIMENTALinduced T cell with suppressive function
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juntendo Universitylead
- Junten Bio Co., Ltd.collaborator
Study Sites (5)
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
Related Publications (1)
Todo S, Yamashita K, Goto R, Zaitsu M, Nagatsu A, Oura T, Watanabe M, Aoyagi T, Suzuki T, Shimamura T, Kamiyama T, Sato N, Sugita J, Hatanaka K, Bashuda H, Habu S, Demetris AJ, Okumura K. A pilot study of operational tolerance with a regulatory T-cell-based cell therapy in living donor liver transplantation. Hepatology. 2016 Aug;64(2):632-43. doi: 10.1002/hep.28459. Epub 2016 Mar 10.
PMID: 26773713RESULT
Study Officials
- STUDY CHAIR
Koichiro Uchida, M.D.,Ph.D.
Juntendo University Advanced Research Institute for Health Science
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professpr
Study Record Dates
First Submitted
April 9, 2021
First Posted
July 6, 2021
Study Start
December 15, 2020
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share