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CARVYKTI®

(ciltacabtagene autoleucel)

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This information is intended for US healthcare professionals to access current scientific information about Janssen products. It is prepared by Janssen Medical Information and is not intended for promotional purposes, nor to provide medical advice.

CARVYKTI® (ciltacabtagene autoleucel)

Medical Information

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CARVYKTI - Mechanism of Action

Last Updated: 02/06/2024

Graphical user interface Description automatically generated

Abbreviations: BCMA, B-cell maturation antigen; CAR, chimeric antigen receptor; CD, cluster of differentiation; Cilta-cel, ciltacabtagene autoleucel; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma.

aCARVYKTI Prescribing Information (2022).1 bJayaraman (2020).2 cHartmann (2017).3 dWeinkove (2019).4 eMadduri (2020).5 fBerdeja (2021).6 gCho (2018).7

SUMMARY

  • CARVYKTI (ciltacabtagene autoleucel; cilta-cel) is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.1
  • CARVYKTI is prepared from the patient’s peripheral blood mononuclear cells which are enriched for T cells and genetically modified ex vivo to express a CAR comprising an anti-BCMA targeting domain, which consists of 2 single-domain antibodies linked to
    4-1BB costimulatory domain and a cluster of differentiation (CD)3-zeta (CD3ζ) signaling domain.1

PRODUCT LABELING

Description

  • CARVYKTI is a BCMA-directed genetically modified autologous T cell immunotherapy.1
  • CARVYKTI is prepared from the patient’s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells and genetically modified ex vivo by transduction with a replication-incompetent lentiviral vector to express a CAR comprising an anti-BCMA targeting domain, which consists of 2 single-domain antibodies linked to a 4-1BB costimulatory domain and a CD3-zeta signaling domain.1

Clinical Pharmacology

Mechanism of Action

  • CARVYKTI is a BCMA-directed, genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a CAR that identifies and eliminates cells that express BCMA.1
  • The CARVYKTI CAR protein features 2 BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA, a 4-1BB costimulatory domain and a CD3-zeta (CD3ζ) signaling cytoplasmic domain.1
  • Upon binding to BCMAexpressing cells, the CAR promotes T cell activation, expansion, and elimination of target cells.1

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on
16 January 2024.

 

References

Show
1 CARVYKTI (ciltacabtagene autoleucel) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf.  
2 Jayaraman J, Mellody M, Hou A, et al. CAR-T design: elements and their synergistic function. EBioMedicine. 2020;58:102931.  
3 Hartmann J, Schüßler‐Lenz M, Bondanza A, et al. Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts. Embo Mol Med. 2017;9(9):1183-1197.  
4 Weinkove R, George P, Dasyam N, et al. Selecting costimulatory domains for chimeric antigen receptors: functional and clinical considerations. Clin Transl Immunol. 2019;8(5):e1049.  
5 Fan F. Durable remissions with BCMA specific chimeric antigen receptor (CAR)-modified T cells in patients with refractory/relapsed multiple myeloma. Poster presented at: The 5th Multiple Myeloma Immunotherapy Workshop; May 2-5, 2019; Denver, CO.  
6 Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324.  
7 Cho S, Anderson K, Tai Y. Targeting B cell maturation antigen (BCMA) in multiple myeloma: potential uses of BCMA-based immunotherapy. Front Immunol. 2018;9:1821.