A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia

Date receipt dossier

EudraCT number

2014-003060-20

Company / Sponsor

Novartis Pharma Services AG

Phase

II

Treated organism

Humans

Indication category

Cancer therapy

Disease

Leukemia

Therapeutic approach

Immunotherapy

Genetic modification

Chimeric antigen receptor against CD19

Method of transfer of nucleic acid of interest

Lentiviral vector

Administered biological material

T-cells transduced with lentiviral vector expressing anti-CD19 CAR

Route of administration

Intravenous

Locations in Belgium

UZ Gent

Type of procedure

Contained use only

Current status

Authorized

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