Induction of Transplant Tolerance in LDLT Via iTS

• ClinicalTrials.gov Identifier: NCT04950842
• Recruitment Status: Active, not recruiting
• First Posted: July 6, 2021
• Last Update Posted: March 28, 2024
• Sponsor: Juntendo University
• Collaborator: Junten Bio Co., Ltd.
• Information provided by (Responsible Party): Koichiro Uchida, Juntendo University

Tracking Information

• First Submitted Date: April 9, 2021
• First Posted Date: July 6, 2021
• Last Update Posted Date: March 28, 2024
• Actual Study Start Date: December 15, 2020
• Estimated Primary Completion Date: February 28, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 25, 2021)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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".

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Living-donor Liver Transplantation

Intervention

Biological: JB-101

induced T cell with suppressive function

Study Arms

Experimental: JB-101

induced T cell with suppressive function

Intervention: Biological: JB-101

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 25, 2021): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2026
• Estimated Primary Completion Date: February 28, 2026 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04950842
• Other Study ID Numbers: jRCT2073200067
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Koichiro Uchida, Juntendo University
• Original Responsible Party: Same as current
• Current Study Sponsor: Juntendo University
• Original Study Sponsor: Same as current
• Collaborators: Junten Bio Co., Ltd.

Investigators

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

• PRS Account: Juntendo University
• Verification Date: March 2024