RecruitingEarly Phase 1NCT06972069

Tolerance Through Mixed Chimerism (Sip-Tego)

Sponsor

Tatsuo Kawai, MD, PhD

Enrollment

12 participants

Start Date

May 31, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Failure Transplant Recipient (Kidney)Immunosuppresion Transplant Tolerance Immunosuppression After Kidney Transplantation

Summary

This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Combined Kidney/Bone Marrow Transplant, a drug called Conditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart), and others for people with immunosuppresion, immunosuppression after kidney transplantation, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECombined Kidney/Bone Marrow Transplant

The conditioning regimen to be used in this protocol consists of an ordered series of procedures and treatments including thymic irradiation, low-dose cyclophosphamide, antibody administration (Siplizumab, rituximab and tegoprubart), and bone marrow cell infusion.

PROCEDUREDonation of Kidney / Bone Marrow

The donor will undergo nephrectomy and under general anesthesia. Donors will undergo bone marrow harvested under general anesthesia. Sufficient marrow will be obtained to provide at least 2 x 108 nucleated cells per kilogram weight of the recipient.

DRUGConditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart)

Recipients will receive a conditioning regimen that includes rituximab on study day -6 and -2, Siplizumab (0.6mg/kg) on day -6, -1, 0 and +1, cyclophosphamide (CP, 22.5mg/kg) on days -5 and -4. Tegoprubart (Fc-modified anti-CD154 mAB, Eledon Pharm) 20mg/kg will be administered on days 0, 2, 5, 12 and 19).