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

EudraCT number

2023-503830-27, 2022-502661-23-00

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, AZ Delta

Nr of subjects

45

Foreseen duration

1/9/2021-1/9/2031

Type of procedure

Contained use only

Current status

Authorized

Pharmaceutical study code

GLPG5101 (19CP02)

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