Drug intelligence / Profile preview

sizavaleucel

Development stage
Phase 3
Lead developer
Medeor Therapeutics
Modality
Stem Cell Therapies → Cell Therapies
Administration
Intravenous
01

Overview

MDR-101 (sizavaleucel) is a personalized, single-dose cellular immunotherapy developed by Medeor Therapeutics for the induction of immune tolerance in HLA-matched living donor kidney transplant recipients. The therapy is composed of CD34+ hematopoietic stem cells and T cells derived from the kidney donor. By establishing mixed chimerism—a state where donor and recipient immune cells coexist—MDR-101 aims to reprogram the recipient's immune system to recognize the donor organ as self. This approach is intended to allow for the complete withdrawal of chronic immunosuppressive medications, which are associated with significant long-term toxicities, including increased risks of infection, malignancy, and cardiovascular disease. The technology was originally developed at Stanford University and is currently being evaluated in the pivotal Phase 3 MERCURY clinical trial.

Other names
MDR productcellular immunotherapydonor-specific cell therapy

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