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TACATRESGENE AUTOLEUCEL

UNII:AD2HJ5CF2N
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:TACATRESGENE AUTOLEUCEL
GSRS Full Record:

  • AUTOLOGOUS T CELLS OBTAINED FROM THE PERIPHERAL BLOOD OF PATIENTS, COLLECTED BY LEUKAPHERESIS, MODIFIED BY CRISPR/CAS9 (CLUSTERED REGULARLY INTERSPACED SHORT PALINDROMIC REPEATS/CRISPR-ASSOCIATED PROTEIN 9) MEDIATED GENE EDITING CONSISTING OF TWO GUIDE RNAS (GRNAS) INTRODUCED TRANSIENTLY AS RIBONUCLEOPROTEIN (RNP) COMPLEX, AND A NEOEPITOPE T CELL RECEPTOR (NEO-TCR) GENE CASSETTE ENCODED BY PLASMID DNA TO REPLACE THE ENDOGENOUS T CELL RECEPTOR (TCR) WITH A SINGLE PATIENT-DERIVED TUMOUR-SPECIFIC NEO-TCR PER T CELL, WITH A MAXIMUM OF THREE DIFFERENT NEO-TCRS IN THE FINAL DRUG SUBSTANCE. THE CONSTANT ELEMENTS OF THE NEO-TCR ARE IDENTICAL FOR EACH PATIENT AND THE NEO-TCR GENE EXPRESSION IS REGULATED BY THE NATIVE ENDOGENOUS TCR PROMOTER. THE T CELLS ARE CULTURED IN THE PRESENCE OF GROWTH MEDIA CONTAINING IL-7 AND IL-15 AND A COMBINATION OF MEMBRANE BOUND ANTI-CD3 AND ANTI-CD28 FOR ACTIVATION. THE T CELLS ARE PREDOMINANTLY CD4 AND CD8 T CELLS (GENERALLY >80%), INCLUDING TMSC (MEMORY STEM CELLS) AND TCM (CENTRAL MEMORY) PHENOTYPES
  • tacatresgene autoleucel [INN]



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