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CLDN18.2 CAR-iNKT is an allogeneic, "off-the-shelf" cell therapy candidate being developed by Arovella Therapeutics for the treatment of Claudin 18.2-positive solid tumors, including gastric, esophageal, and pancreatic cancers. The therapy utilizes invariant Natural Killer T (iNKT) cells derived from healthy donor peripheral blood mononuclear cells (PBMCs). These cells are engineered with a second-generation chimeric antigen receptor (CAR) featuring a high-affinity single-chain variable fragment (scFv) derived from the SPX-101 monoclonal antibody. To enhance persistence and anti-tumor activity within the immunosuppressive tumor microenvironment, the cells are "armoured" with membrane-bound Interleukin-12 (IL-12-TM). iNKT cells offer a unique dual-action mechanism, engaging tumors through both the engineered CAR and their endogenous semi-invariant T cell receptor (iTCR), which recognizes glycolipid antigens presented by CD1d, while naturally avoiding graft-versus-host disease (GvHD).
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