Study 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 or Small Lymphocytic Lymphoma (SLL)
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 or Small Lymphocytic Lymphoma (SLL)
Date receipt dossier:
25 Jul 2022
EudraCT number:
2021-003815-25
Pharmaceutical study code:
CP0101-CLL
Company / Sponsor:
CellPoint B.V.
Phase:
I/II
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
relapsed / refractory chronic lymphocytic leukemia relapsed / refractory small lymphocytic lymphoma
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:
CHU Liège
Type of procedure:
Contained use only
Current status:
Authorized