A Phase 2, Open-Label, Randomized, Multicenter Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis (KYSA-7)

Long title

A Phase 2, Open-Label, Randomized, Multicenter Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis (KYSA-7)

Date receipt dossier

EudraCT number

2024-511168-10

Company / Sponsor

Kyverna Therapeutics, Inc.

Phase

II

Treated organism

Humans

Indication category

Immune disease

Disease

Multiple Sclerosis

Therapeutic approach

Immunotherapy

Genetic modification

CD19 CAR

Method of transfer of nucleic acid of interest

Lentiviral vector

Administered biological material

Autologous T cells transduced with lentiviral vectors expressing CD19-CAR

Route of administration

Intravenous

Locations in Belgium

UZ Antwerpen

Foreseen duration

May 2024-31 May 2027

Type of procedure

Contained use only

Current status

Authorized

Pharmaceutical study code

KYV-101

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