In Silico Quantitative Systems Pharmacology, CMC Bioprocess Modeling, and Safety Evaluation of OMNI-CAR: A Low-Cost, In Vivo Targeted mRNA-LNP Universal Modular CAR-T Platform with Boolean Logic and Stroma Remodeling

Background

Chimeric Antigen Receptor (CAR) T-cell therapy has revolutionized hematologic oncology, but its translation to solid tumors is impeded by three prohibitive barriers: exorbitant manufacturing costs ($375,000–$500,000 COGS, exceeding $1M total per patient), acute toxicities (CRS, ICANS, and on-target off-tumor destruction), and the hostile, desmoplastic immunosuppressive solid tumor microenvironment (TME).