Study title:
A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r NHL) (CP0201-NHL)
Long title:
A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r NHL) (CP0201-NHL)
Date receipt dossier:
18 Jan 2024
EudraCT number:
2023-503830-27
Pharmaceutical study code:
GLPG5101 (19CP02)
Company / Sponsor:
Galapagos NV
Phase:
I/II
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
relapsed/refractory B-cell non-Hodgkin lymphoma (r/r NHL)
Therapeutic approach:
Immunotherapy
Genetic modification:
BCMA CAR
Method of transfer of nucleic acid of interest:
Lentiviral vector
Administered biological material:
Autologous T cells transduced with lentiviral vectors expressing BCMA-CAR
Route of administration:
Intravenous
Locations in Belgium:
UZ Leuven
Type of procedure:
Contained use only
Current status:
Authorized