The United Kingdom's Medicines Healthcare Products Regulatory Agency (MHRA) has granted authorisation for the first-in-human clinical trial to assess United States-based Sangamo Therapeutics' Chimeric Antigen Receptor Regulatory T Cell (CAR-Treq) therapy TX200, it was reported yesterday.

TX200 is being studied for the prevention of immune-mediated rejection following HLA-A2 mismatched kidney transplantation for end-stage renal disease (ESRD). It is an autologous (cells collected from the patient) HLA-A2-targeted CAR-Treg cell therapy. The company aims to open the first clinical sites for the STEADFAST study in 2020.

Adrian Woolfson, BM, BCh, PhD, head of Research and Development at Sangamo, said, 'Being the first company to test a CAR-Treg candidate in humans is an important milestone for Sangamo and this exciting new frontier of cellular therapy. We believe that the TX200 program will be invaluable in expanding our understanding of the safety and mechanism of action of CAR-Treg cells and their relevance in the clinic. This innovative and personalised cellular therapy approach for HLA-A2 mismatched kidney transplantation is designed to help regulate the body's immune system specifically and locally to promote acceptance of an immunologically mismatched donor organ. Beyond transplantation, we plan to explore the potential of CAR-Tregs in a range of autoimmune and inflammatory diseases.'