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- Prescribing Information
- CARVYKTI® REMS
CARVYKTI® is a BCMA-directed CAR-T therapy
CARVYKTI® is an autologous immunotherapy in which a patient’s T cells are genetically modified to encode a chimeric antigen receptor (CAR) to find and destroy B cell maturation antigen (BCMA)–expressing cells. BCMA is overexpressed on the surface of malignant multiple myeloma B-lineage cells; it is also expressed on the surface of late-stage B cells and plasma cells.
CAR-T with 2 BCMA-targeting single-domain antibodies
CAR-T=chimeric antigen receptor-T cell.
Correlation of the mechanism of action with clinical effect has not been established.
Manufacturing CARVYKTI® CAR-T cells
At the manufacturing site, the patient’s T cells are isolated and genetically modified to express the CARVYKTI® CAR.
ISOLATION
The patient's collected cells are cryopreserved and shipped from the leukapheresis center to the manufacturing site. After thawing, the T cells are isolated
MODIFICATION
The patient’s T cells are then genetically modified to express a CAR that targets BCMA with 2 distinct binding domainsa
Target 25-day turnaround CAR-T cell manufacturing timeb
EXPANSION
These anti-BCMA CARVYKTI® CAR-T cells are then expanded in cell culture, washed, put into a suspension, checked for quality control, and cryopreserved for transport to the Certified Treatment Center
BCMA=B cell maturation antigen; CAR=chimeric antigen receptor; CAR-T=chimeric antigen receptor-T cell.
acorrelation of the mechanism of action with clinical effect has not been established.
bDefined as time that elapses from receipt of apheresis at manufacturing site to quality assurance release of finished product.
Learn about the CARVYKTI® treatment process