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

EudraCT number

2023-503830-27

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

Pharmaceutical study code

ALLO-501A

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