Clinical trial NCT04950842: Induction of Transplant Tolerance in LDLT Via iTS
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Living-donor Liver Transplantation
Keywords: living-donor liver transplantation
immunotolerance
operational tolerance
cell therapy
Lead sponsor: Juntendo University
Sponsor class: OTHER
Collaborators: name: Junten Bio Co., Ltd.
First posted: 2021-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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".

Eligibility 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.

Primary outcomes:
measure: Achievement of operational tolerance
timeFrame: immunosuppressive drug cessation was maintained for at least 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bunkyoku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
Study officials:
affiliation: Juntendo University Advanced Research Institute for Health Science
name: Koichiro Uchida, M.D.,Ph.D.
role: STUDY_CHAIR
References:
citation: 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.