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

Study 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
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: 
2 Dec 2019
EudraCT number: 
2019-001730-34
Pharmaceutical study code: 
TX-200-TR101
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