TricDB

lisocabtagene maraleucel

Drug Code : 2202252714
Drug Brand : Breyanzi
Company : Juno Therapeutics Inc
Approved by : FDA
Approval Time : Feb. 2021
Direct Target : CD19
Drug Type : Cell therapy
Gene :
Alteration :
Indications : Lisocabtagene maraleucel is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Limitations of Use: Lisocabtagene maraleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.
Mechanism Of Action :
Lisocabtagene maraleucel is a CD19-directed genetically modified autologous cell immunotherapy administered as a defined composition to reduce variability in CD8-positive and CD4-positive T cell dose. The CAR is comprised of an FMC63 monoclonal antibody-derived single chain variable fragment (scFv), IgG4 hinge region, CD28 transmembrane domain, 4-1BB (CD137) costimulatory domain, and CD3 zeta activation domain. CD3 zeta signaling is critical for initiating activation and antitumor activity, while 4-1BB (CD137) signaling enhances the expansion T cell and persistence of lisocabtagene maraleucel.
Clinical Trial : NCT02631044
Dosage : The dose is 50 to 110 × 106 CAR-positive viable T cells (consisting of CD8 and CD4 components) (2.1, 3). Administer lisocabtagene maraleucel in a certified healthcare facility.
Structure :
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