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drug_type
RELEVANT_DRUG
intervention_type
Cellular therapy (autologous CAR T cells)
drug_description
An autologous, dual-target CD19/BCMA chimeric antigen receptor T-cell (CAR-T) therapy engineered to deplete CD19+ B cells and BCMA+ plasmablasts/plasma cells to ablate autoreactive B-cell compartments in refractory SLE.
nci_thesaurus_concept_id
C175471
nci_thesaurus_preferred_term
Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F
nci_thesaurus_definition
A preparation of autologous T-lymphocytes engineered to express two separate chimeric antigen receptors (CARs) targeting the tumor-associated antigens (TAAs) BCMA and CD19 and fused to as of yet not fully elucidated co-stimulatory domains, with potential immunostimulating and antineoplastic activities. Upon administration, the autologous bispecific BCMA/CD19-targeted CAR-T cells GC012F specifically and simultaneously target and bind to tumor cells expressing BCMA and/or CD19. This induces selective toxicity in tumor cells that express BCMA and/or CD19. BCMA, a tumor-specific antigen and a receptor for both a proliferation-inducing ligand (APRIL) and B-cell activating factor (BAFF), is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and plays a key role in the survival of B-lymphocytes and plasma cells. BCMA is found on the surfaces of B-cells and is overexpressed on malignant plasma cells. CD19 is a B-cell-specific cell surface antigen overexpressed in B-cell lineage malignancies. The processing platform used, FasT CAR-T, shortens the manufacturing time to produce the CAR-T cells within 24 hours.
drug_mesh_term
Chimeric Antigen Receptor T-Cell Therapy
drug_category
CAR T
drug_class
Cellular Therapy
drug_delivery_route
Intravenous
drug_mechanism_of_action
Autologous T cells engineered with dual CARs targeting CD19 and BCMA bind B cells and plasmablasts/plasma cells, triggering CAR signaling that activates T-cell proliferation and cytolytic activity (perforin/granzyme and cytokines) to deplete CD19+ and BCMA+ compartments, thereby abrogating autoreactive B-cell populations and autoantibody production in refractory SLE.
drug_name
GC012F
nct_id_drug_ref
NCT05858684