Cell Therapy for Immunomodulation in Kidney Transplantation

Thomas Wekerle

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Kidney Transplantation

Treatments: Other: Regulatory T cells; Other: Immunosuppressive drug therapy; Procedure: Kidney transplant; Drug: Tocilizumab; Other: Bone marrow

Study type: Interventional

Funder types: Other

Identifiers

NCT03867617

Trex001

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Study group

Experimental group

Description:

Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients

Treatment:

Other: Bone marrow

Drug: Tocilizumab

Procedure: Kidney transplant

Other: Immunosuppressive drug therapy

Other: Regulatory T cells

Control group

Active Comparator group

Description:

Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients

Treatment:

Procedure: Kidney transplant

Other: Immunosuppressive drug therapy