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