Sangamo Gains MHRA Authorization for Clinical Trial of CAR-Treg Therapy

November 21, 2019

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

In a Nov. 19, 2019 press release, Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

Sangamo’s TX200 therapy is being studied to evaluate its ability to prevent immune-mediated rejection following HLA-A2 mismatched kidney transplantation for end-stage renal disease (ESRD). The first in-human clinical study (STEADFAST) of the therapy will be a multicentre, open-label, single ascending dose, dose-ranging Phase I/II study that the company plans to run in five different European countries-the UK, France, Netherlands, Germany, and Belgium.

“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,” said Adrian Woolfson, head of R&D at Sangamo, in the press release. “This innovative and personalized 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.”

Source: Sangamo