Phase I Study of Eight-Treg Cell Therapy to Prevent Rejection in Living Donor Kidney Transplant Patients

What this Trial Is About

Researchers are studying kidney transplantation recipients to evaluate a new type of cell therapy called Eight Treg, which contains regulatory CD8 T cells expanded outside the body. This phase I clinical trial aims to assess the safety of increasing doses of this experimental drug in patients receiving a kidney from a living donor. The study builds on previous research showing the potential of regulatory cells to promote graft tolerance and reduce reliance on traditional immunosuppressive drugs, which can cause side effects and increase infection risks. Participants receive the Eight Treg treatment as an intravenous infusion one day before their kidney transplant surgery. This is given in addition to the standard maintenance immunosuppressive regimen, including corticosteroids, tacrolimus, and MPA, commonly prescribed to kidney transplant patients. The trial will administer escalating doses of the cell therapy to evaluate its safety and feasibility according to good manufacturing practices. This is the first time expanded CD8 Tregs are administered to humans in this context. During the study, participants are monitored closely for treatment-related adverse events up to three months post-transplant and for dose-limiting toxicities. Additional evaluations include graft inflammation, immune response profiles, infection rates, and overall immunosuppressive burden over one year. Blood samples are analyzed to characterize immune cell responses using flow cytometry and gene sequencing techniques. The study involves follow-up visits up to 12 months after transplantation to assess long-term safety and biological effects of the therapy.

Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients