Drug intelligence / Profile preview

FMC63-4-1BBζ CAR T

Development stage
Approved
Lead developer
Novartis
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies
Administration
Intravenous
01

Overview

FMC63-4-1BBζ CAR T is a second-generation chimeric antigen receptor (CAR) T-cell therapy engineered to target the CD19 antigen, which is expressed on the surface of most B-cell malignancies. The construct consists of a single-chain variable fragment (scFv) derived from the FMC63 murine monoclonal antibody for antigen recognition, coupled with a 4-1BB (CD137) costimulatory domain and a CD3ζ signaling domain. This specific molecular architecture is the basis for the FDA-approved therapies tisagenlecleucel (Kymriah) and lisocabtagene maraleucel (Breyanzi). The inclusion of the 4-1BB domain is designed to enhance the metabolic fitness, expansion, and long-term persistence of the T cells in vivo compared to first-generation or CD28-based CARs. It is primarily used to treat relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and various B-cell non-Hodgkin lymphomas (B-NHL).

Brand names
KymriahBreyanzi
Other names
tisagenlecleucellisocabtagene maraleucelCD19-4-1BB-CD3ζ CAR-TFMC63-41BBζ CAR
02

Targets

TNFRSF9 (CD137 extracellular domain)CD19 (B lymphocyte antigen CD19)CD247 (T-cell surface glycoprotein CD3 epsilon chain)

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