Study title:
A randomized, open-label, Phase 2 study evaluating lymphodepletion with fludarabine (F), cyclophosphamide (C), and ALLO-647 (A) vs FC alone, in subjects with R/R LBCL receiving ALLO-501A allogeneic CAR T cell therapy
Long title:
A randomized, open-label, Phase 2 study evaluating lymphodepletion with fludarabine (F), cyclophosphamide (C), and ALLO-647 (A) vs FC alone, in subjects with R/R LBCL receiving ALLO-501A allogeneic CAR T cell therapy
Date receipt dossier:
22 May 2023
EudraCT number:
2023-503830-27
Pharmaceutical study code:
ALLO-501A
Company / Sponsor:
Allogene therapeutics
Phase:
II
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
diffuse large B-cell lymphoma (DLBCL)
Therapeutic approach:
Immunotherapy
Genetic modification:
CD19 CAR + knockouts CD52 and TRAC via TALEN technology
Method of transfer of nucleic acid of interest:
Lentiviral vector
Administered biological material:
Allogeneic T cellstransduced with lentiviral vectors expressing CD19 CAR; TRAC (T Cell Receptor Alpha Constant) and CD52 knockout genes by TALEN technology
Route of administration:
Intravenous
Locations in Belgium:
UZ Leuven, UZ Brussel, Cliniques universitaires Saint-Luc, ZNA
Type of procedure:
Contained use only
Current status:
Authorized