Study title:
A single-arm, open-label, multi-centre, phase I/II study evaluating the safety and clinical activity of QEL-001, an autologous CAR T regulatory cell treatment targeting HLA-A2, in HLA-A2/ A28neg patients that have received an HLA-A2pos liver transplant
Long title:
A single-arm, open-label, multi-centre, phase I/II study evaluating the safety and clinical activity of QEL-001, an autologous CAR T regulatory cell treatment targeting HLA-A2, in HLA-A2/ A28neg patients that have received an HLA-A2pos liver transplant
Date receipt dossier:
2 Sep 2022
EudraCT number:
2021-001379-18
Pharmaceutical study code:
QEL-001
Company / Sponsor:
Quell Therapeutics Limited
Phase:
I/II
Treated organism:
Humans
Indication category:
Infectious disease
Disease:
Anti-graft rejection treatment
Therapeutic approach:
Anti-graft rejection treatment
Genetic modification:
BCMA CAR; shRNA CD3ζ; tCD34
Method of transfer of nucleic acid of interest:
Moloney murine leukemia virus
Administered biological material:
Autologous T-cells retrovirally transduced with BCMA-CAR, ShRNA CD3ζ and tCD34
Route of administration:
Intravenous
Locations in Belgium:
UZ Leuven, Cliniques Universitaires Saint-Luc, Institut Jules Bordet
Type of procedure:
Contained use only
Current status:
Authorized