Nov 19, 2019: Sangamo Therapeutics announced that the UK Medicines Healthcare Products Regulatory Agency (MHRA) has granted authorization of the first-in-human clinical trial to evaluate a Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) therapy TX200 for the prevention of immune-mediated rejection following HLA-A2 mismatched kidney transplantation for end-stage renal disease (ESRD).
In 2020 Sangamo expects to open this first clinical sites for the STEADFAST study.This inventive and personalized cellular therapy approach for HLA-A2 mismatched kidney transplantation is planned to regulate the body’s immune system specifically and locally to promote reception of an immunologically mismatched donor organ.
TX200 is an autologous (cells collected from the patient) HLA-A2-targeted CAR-Treg cell therapy. The patient’s regulatory T cells (Tregs) plays vital role in regulating the immune response and inflammation, are collected and genetically engineered with a Chimeric Antigen Receptor (CAR) intended to bind to HLA-A2(protein).
TX200 HLA-A2 CAR-Treg cells are planned to accumulate and restrict within the new kidney where the HLA‑A2 protein is present, in order to utilizing the ability of Tregs to suppress immune responses against the transplanted kidney.
This aims to help the recipient’s immune system to accept the new kidney and induce immunological tolerance, potentially allowing tapering and eventual elimination of accompanying standard-of-care immune suppressive treatments. https://investor.sangamo.com/news-releases/news-release-details/sangamo-announces-uk-authorization-phase-12-clinical-trial