A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant

Long title

A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant recipients

Date receipt dossier

EudraCT number

2019-001730-34

Company / Sponsor

Sangamo therapeutics

Phase

I/II a

Treated organism

Humans

Indication category

Immunological rejection

Disease

Living donor renal transplant recipients

Therapeutic approach

Prevention

Genetic modification

chimeric antigen receptor specific to the donor HLA A*2

Method of transfer of nucleic acid of interest

Recombinant lentiviral vectors

Administered biological material

Autologous T-cells transduced with lentiviral vector expressing CAR specific to the donor HLA A*2

Route of administration

Intravenous

Locations in Belgium

Autologous T-cells transduced with lentiviral vector expressing CAR specific to the donor HLA A*2

Type of procedure

Contained use only

Current status

Authorized

Pharmaceutical study code

TX-200-TR101

© Sciensano - Version 1.0 (20260902.1)