dm+d

Unassigned

New Medicines

Kidney transplant rejection - prevention

Information

New molecular entity
Sangamo
Sangamo

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
None

Category

A chimeric antigen receptor, engineered regulatory T cell (CAR-Treg) based cellular immunotherapy, given in a single dose
The UK has a relatively high rate of kidney transplants compared to most European Union nations. With a rate of 54.5 kidney transplants per million population in 2019. This was the fourth highest in the EU. The only countries with a higher rate than the UK in this year were the Netherlands, France and Spain [1].
Kidney transplant rejection - prevention
Intravenous infusion

Trial or other data

Mar 21PI/IIa STEADFAST trial to evaluate the safety and tolerability of TX 200 in living donor renal transplant recipients starts (TX200-KT02; TX200-TR101-DS; NCT04817774). The non-randomised, open-label trial intends to enrol 42 adults in the UK (at Oxford University Hospitals NHS Foundation Trust), the Netherlands and Belgium. The study requires three different types of participants - transplant recipients who will receive the study treatment TX200-TR101; control participants, who are transplant recipients who will not receive the study treatment; and transplant donors, who will donate their kidney to the transplant recipients. Subjects undergo kidney transplant as per planned standard of care and are administered study drug post transplantation, up to 15 subjects. TX200-TR101 is an autologous gene therapy medicinal product composed of Treg cells (CD4+/CD45RA+/CD25+/CD127low/neg) that have been ex vivo expanded and transduced with a lentiviral vector encoding for a CAR to recognize HLA-A*02. Treatment will be given via an IV infusion at a pre-defined timepoint several weeks after transplant. Three, single ascending dose cohorts of TX200-TR101 are planned and an additional expansion cohort. Collection of primary outcome data is due to complete Nov 24 [2].