Long title
A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (CP0101-CLL) – Euplagia-1
Date receipt dossier
EudraCT number
2022-501686-47; 2021-003815-25
Company / Sponsor
CellPoint B.V. (a Galapagos company)
Phase
I/II
Treated organism
Humans
Indication category
Cancer therapy
Disease
relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Therapeutic approach
Immunotherapy
Genetic modification
CD19 CAR
Method of transfer of nucleic acid of interest
Lentiviral vector
Administered biological material
Autologous T cells transduced with lentiviral vectors expressing CD19-CAR
Route of administration
Intravenous
Locations in Belgium
UZ Leuven; AZ Delta; CHU Liège; AZ Antwerpen
Nr of subjects
45 trial subjects for the entire study, 6 for the study conducted in UZ Leuven
Foreseen duration
25 December 2021-25 December 2031
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
GLPG5201 (BCN-CP01)