drug_type
RELEVANT_DRUG
intervention_type
cellular immunotherapy (CAR-NK)
drug_description
Allogeneic induced-pluripotent-stem-cell–derived CD19-directed CAR-NK cell therapy; engineered NK cells recognize CD19 on malignant B cells and kill via NK cytotoxic pathways.
nci_thesaurus_concept_id
C187301
nci_thesaurus_preferred_term
Allogeneic iPSC-derived Anti-CD19-CAR/IL-15-expressing NK Cells CNTY-101
nci_thesaurus_definition
A preparation of allogeneic natural killer (NK) cells derived from a clonal master induced pluripotent stem cell (iPSC) line, and engineered to express a chimeric antigen receptor (CAR) consisting of an anti-CD19 single chain variable fragment (scFv) derived from the anti-CD19 monoclonal antibody FMC63 and coupled to the CD28 and zeta chain of the TCR/CD3 complex (CD3-zeta) costimulatory signaling domains, and interleukin 15 (IL-15), with potential immunostimulatory and antineoplastic activities. Upon administration, allogeneic iPSC-derived anti-CD19-CAR/IL-15-expressing NK cells CNTY-101 recognize, bind to and induce selective cytotoxicity in CD19-expressing tumor cells. IL-15 is a pro-survival cytokine that promotes T-cell persistence and potentiates the immune response against tumor cells. The human tumor associated antigen (TAA) CD19 is a B-cell specific cell surface antigen expressed in all B-cell lineage malignancies. CNTY-101 is also engineered with a safety switch composed of a shorter version of the extracellular domain of human epidermal growth factor receptor (EGFR). This allows the elimination of CNTY-101 upon the administration of anti-EGFR antibodies such as cetuximab. In addition, CNTY-101 is gene-edited to prevent its elimination by the patients NK cells, CD4 and CD8 T-cells.
drug_category
CAR NK
drug_class
Cellular Therapy
drug_delivery_route
Intravenous
drug_mechanism_of_action
Allogeneic iPSC-derived NK cells engineered with an anti-CD19 CAR (FMC63 scFv with CD28/CD3ζ signaling) and IL-15 recognize CD19 on malignant B cells and kill them via NK cytotoxic pathways; IL-15 enhances NK survival/persistence. Cells include a truncated EGFR safety switch enabling elimination with cetuximab and gene edits to reduce rejection by host immune cells.
drug_name
CNTY-101
nct_id_drug_ref
NCT05336409