A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Long title

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Date receipt dossier

EudraCT number

2024-511188-26

Company / Sponsor

Kite Pharma

Phase

III

Treated organism

Humans

Indication category

Cancer therapy

Disease

multiple myeloma

Therapeutic approach

Immunotherapy

Genetic modification

ddBCMA CAR

Method of transfer of nucleic acid of interest

Lentiviral vector

Administered biological material

Autologous T cells transduced with lentiviral vectors expressing D-domain BCMA-CAR

Route of administration

Intravenous

Locations in Belgium

UZ Leuven, Cliniques Universitaires Saint-Luc, UZ Antwerpen, U Gent

Nr of subjects

450

Foreseen duration

2024-2041

Type of procedure

Contained use only

Current status

Authorized

Pharmaceutical study code

CART-ddBCMA-cel

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