Drug intelligence / Profile preview

ARI0002h

Development stage
Phase 2
Lead developer
Hospital Clínic de Barcelona-IDIBAPS
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

ARI0002h is an academic, autologous, B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy designed for the treatment of relapsed or refractory multiple myeloma. The therapy uses a lentiviral vector to engineer the patient's own T cells to express a CAR that contains a humanized single chain variable fragment (scFv) targeting BCMA and a 4-1BB co-stimulatory domain, enhancing T-cell activation and persistence. Developed and produced at Hospital Clínic Barcelona and IDIBAPS, ARI0002h is notable as the first European academic CAR T-cell product for multiple myeloma, aiming to provide high efficacy with a favorable safety profile and lower cost compared to commercial CAR-T products. The therapy uses fractionated initial dosing and a booster dose after 100 days, resulting in deep and durable responses, high rates of minimal residual disease (MRD) negativity, and manageable toxicity, predominantly low-grade cytokine release syndrome and minimal neurotoxicity[1][2][3][5][7].

Brand names
ARI0002hARI-0002hARI 0002h
Other names
cesnicabtagene autoleucel
02

Targets

BCMA (B-cell maturation antigen)

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