drug_type
RELEVANT_DRUG
intervention_type
Cellular therapy (CAR T cells)
drug_description
Autologous, fully human anti-CD19 chimeric antigen receptor T-cell therapy that depletes CD19+ B-lineage cells to reduce pathogenic autoantibodies in generalized myasthenia gravis.
nci_thesaurus_concept_id
C210038
nci_thesaurus_preferred_term
Autologous Anti-CD19 CAR-CD8alpha-CD28-CD3zeta T Cells KYV 101
nci_thesaurus_definition
A preparation of autologous CD4- and CD8-positive T-cells that are transduced with a lentiviral vector encoding for a chimeric antigen receptor (CAR) consisting of a human single chain variable fragment (scFv) of anti-CD19 and fused to the hinge and transmembrane domains of CD8alpha co-receptor, the cytoplasmic costimulatory domain of human CD28, and the T-cell antigen receptor complex zeta chain (CD3-zeta), with potential immunostimulating activity. Upon transfusion, autologous anti-CD19 CAR-CD8alpha-CD28-CD3zeta T cells KYV 101 recognize and induce selective toxicity and lysis in CD19-expressing B-cells. CD19, a B-cell-specific cell surface antigen, is overexpressed in B-cell lineage malignancies and in certain B-cell-driven autoimmune diseases.
drug_category
CAR T
drug_class
Cellular Therapy
drug_delivery_route
Intravenous
drug_mechanism_of_action
Autologous T cells are engineered with a lentiviral vector to express an anti-CD19 chimeric antigen receptor (scFv-CD19 with CD8α hinge/transmembrane, CD28 costimulatory, and CD3ζ signaling domains). After infusion, the CAR T cells recognize CD19 on B-lineage cells (B cells and plasmablasts), become activated, and mediate cytotoxic lysis, depleting CD19+ cells and reducing pathogenic autoantibody production in generalized myasthenia gravis.
drug_name
KYV-101
nct_id_drug_ref
NCT06193889