Cell Therapy for Immunomodulation in Kidney Transplantation

A Prospective Controlled Trial to Evaluate Safety and Efficacy of in Vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-mismatched Living Donor Kidney Transplant Recipients

This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: Regulatory T cells; Drug: Tocilizumab; Other: Bone marrow; Procedure: Kidney transplant; Other: Immunosuppressive drug therapy

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Thomas Wekerle, MD; Phone Number: 39380 +43-1-40400; Email: Thomas.Wekerle@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna/Vienna General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient has provided written informed consent.
• Patient is 18 years or older.
• Patient is a planned recipient of a living donor kidney transplant.
• Patient is a planned recipient of an ABO blood group-compatible kidney graft.
• Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical.
• Patient is negative for DSA (donor-specific antibodies).
• WOCBP (women of child-bearing potential) must have a negative pregnancy test at inclusion.
• WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

• Patient is EBV (epstein barr virus)-negative on serology.
• Patient is HIV-positive or suffering from chronic viral hepatitis.
• Patient is CMV (cytomegalo virus)-negative and receiving a kidney from a CMV-positive donor.
• Positive T-cell lymphocytotoxic cross match.
• Patient with prior kidney transplant or non-renal solid organ transplant.
• Patient has a known contraindication to any of the protocol-specified treatments.
• Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin.
• Female patients who are breast-feeding.
• Female patients with a positive pregnancy test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients	Other: Regulatory T cells; Single infusion of expanded regulatory T cells.; Drug: Tocilizumab; Treatment during first month post-transplant.; Other: Bone marrow; Infusion of donor bone marrow cells.; Procedure: Kidney transplant; Living donor kidney transplantation.; Other: Immunosuppressive drug therapy; Immunosuppressive drug therapy.
Active Comparator: Control group; Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients	Procedure: Kidney transplant; Living donor kidney transplantation.; Other: Immunosuppressive drug therapy; Immunosuppressive drug therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death	Incidence of composite safety endpoint by 12 months post-transplant.	12 months
Chimerism	Total leukocyte donor chimerism in blood.	1 month

Collaborators and Investigators

• Sponsor: Thomas Wekerle
• Collaborators: University Hospital Regensburg
• Investigators: Principal Investigator: Thomas Wekerle, MD, Medical University of Vienna

Publications and helpful links

General Publications

• Oberbauer R, Edinger M, Berlakovich G, Kalhs P, Worel N, Heinze G, Wolzt M, Lion T, Wekerle T. A Prospective Controlled Trial to Evaluate Safety and Efficacy of in vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-Mismatched Living Donor Kidney Transplant Recipients (Trex001). Front Med (Lausanne). 2021 Jan 27;7:634260. doi: 10.3389/fmed.2020.634260. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 8, 2019

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: Trex001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No