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NLIR + FU/FA is a combination therapy regimen developed by Sorrento Therapeutics for the treatment of CEA-expressing pancreatic adenocarcinoma with liver metastases. The regimen consists of regional hepatic infusions of autologous anti-CEA CAR-T cells (referred to as NLIR or CAR2) alternating with systemic chemotherapy comprising 5-fluorouracil (FU) and folinic acid (FA, also known as leucovorin). The CAR-T cells are engineered to target Carcinoembryonic Antigen (CEA), a protein frequently overexpressed in gastrointestinal cancers. The NLIR (Next-generation Liver-Intra-arterial Regional) delivery method utilizes the TriSalus Pressure-Enabled Drug Delivery (PEDD) device to administer the CAR-T cells directly into the hepatic artery, aiming to overcome the high interstitial fluid pressure of solid tumors and enhance the infiltration of the engineered T cells into liver metastases. The alternating systemic FU/FA chemotherapy is intended to provide synergistic anti-tumor activity and systemic disease control.
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