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 (Trex)

Phase 1

Recruiting

• Conditions: Kidney transplantation; MedDRA version: 20.0Level: LLTClassification code: 10023438Term: Kidney transplant Class: 10042613; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2024-513459-34-00
• Lead Sponsor: Medical University Of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

For recipients (study and control group): Patient has provided written informed consent., For donors (study group only): Participant is 18 years or older., For donors (study group only): Participant is suitable to donate bone marrow according to the guidelines of the Department of Blood Group Serology and Transfusion Medicine., For donors (study group only): WOCBP must not be pregnant at inclusion (i.e. negative pregnancy test)., For donors (control group only): Participant has provided written informed consent to donate blood for immune monitoring analyses., For donors (control group only): Participant is 18 years or older., For recipients (study and control group): Patient is 18 years or older., For recipients (study and control group): Patient is a planned recipient of a living donor kidney transplant., For recipients (study and control group): Patient is a planned recipient of an ABO-compatible kidney graft., For recipients (study and control group): Patient is a planned recipient of a kidney graft from a donor that is not HLA-identical., For recipients (study and control group): Patient is negative for DSA., For recipients (study and control group): WOCBP must have a negative pregnancy test at inclusion., For recipients (study and control group): 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., For donors (study group only): Participant has provided written informed consent.

Exclusion Criteria

For recipients (study and control group): Patient is EBV-negative on serology., For recipients (study and control group): Patient is HIV-positive or suffering from chronic viral hepatitis., For recipients (study and control group): Patient is CMV-negative and receiving a kidney from a CMV-positive donor., For recipients (study and control group): Positive T-cell lymphocytotoxic cross match., For recipients (study and control group): Patient with prior kidney transplant or non-renal solid organ transplant., For recipients (study and control group): Patient has a known contraindication to any of the protocol-specified treatments, For recipients (study and control group): 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., For recipients (study and control group): Female patients who are breast-feeding., For recipients (study and control group): Female patients with a positive pregnancy test.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified