A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia

Date receipt dossier

EudraCT number

2016-001706-42

Company / Sponsor

Celgene

Phase

II

Treated organism

Humans

Indication category

Cancer therapy

Disease

Acute lymphoblastic leukemia

Therapeutic approach

Immunotherapy

Genetic modification

Chimeric antigen receptor against CD19

Method of transfer of nucleic acid of interest

Gamma-retroviral vectors

Administered biological material

T-cells transduced with gamma-retroviral vectors to express chimeric antigen receptor (CAR) against CD19

Route of administration

Intravenous

Locations in Belgium

UZ Gent

Nr of subjects

25 participants

Type of procedure

Contained use only

Current status

Authorized

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