drug_type
RELEVANT_DRUG
intervention_type
Gene-modified autologous cellular immunotherapy
drug_description
Autologous, gene-modified cellular immunotherapy composed of peripheral blood monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR); administered as a single IV infusion (3 or 10 billion CAR+ cells). CAR recognition of HER2 on tumor cells activates monocytes, which traffic to tumors, differentiate into macrophages, and eliminate HER2+ cells via phagocytosis/cytotoxic effector functions while presenting tumor antigens and modulating the tumor microenvironment.
nci_thesaurus_concept_id
C205637
nci_thesaurus_preferred_term
Autologous Anti-HER2 CAR Monocytes CT-0525
nci_thesaurus_definition
A preparation of autologous monocytes genetically modified to express a chimeric antigen receptor (CAR) specific for the tumor-associated antigen (TAA) human epidermal growth factor receptor 2 (HER2; ErbB2; HER-2), with potential immunostimulating and antineoplastic activities. Upon administration, autologous anti-HER2 CAR monocytes CT-0525 specifically recognize and bind to HER2-expressing tumor cells, and expose the immune system to the HER2 antigen. This may elicit a cytotoxic T-lymphocyte (CTL) response against HER2-expressing tumor cells. HER2 is overexpressed in a variety of cancer cell types and is associated with increased tumor cell proliferation.
drug_category
CAR M
drug_class
Cellular Therapy
drug_delivery_route
Intravenous
drug_mechanism_of_action
Autologous peripheral blood monocytes are engineered ex vivo to express an anti-HER2 chimeric antigen receptor. After infusion, CAR engagement of HER2 on tumor cells activates the monocytes, which traffic to tumors and differentiate into macrophages that eliminate HER2-positive cells via phagocytosis and other cytotoxic effector functions, while presenting tumor antigens and reshaping the tumor microenvironment to promote secondary adaptive immune responses.
drug_name
CT-0525
nct_id_drug_ref
NCT06254807