Study Design: Human Leukocyte Antigen Class I Molecule A∗02-Chimeric Antigen Receptor Regulatory T Cells in Renal Transplantation
Katharina Schreeb, Emily J Culme-Seymour, Essra Ridha, Céline Dumont, Gillian Atkinson, Benjamin Hsu, Petra Reinke
Abstract
Introduction: 02-positive donor kidney. Methods: This article describes the design of the STEADFAST study, a first-in-human, phase I/IIa, multicenter, open-label, single-ascending dose, dose-ranging study to assess TX200-TR101 in living-donor renal transplant recipients. Up to 15 transplant recipients will receive TX200-TR101 and will be followed up for a total of 84 weeks post-transplant, alongside a control cohort of up to 6 transplant recipients. All transplant recipients will receive a standard of care immunosuppressive regimen, with the intent of intensified tapering of the regimen in the TX200-TR101 cohort. Results: The primary end point is the incidence and severity of treatment-emergent adverse events (AEs) within 28 days post-TX200-TR101 infusion. Other end points include additional safety parameters, clinical and renal outcome parameters, and the evaluation of biomarkers. Conclusion: 02-mismatched renal transplantation.