RiboX's Circular RNA CAR-T IND Clearance Forces the Industry to Rethink Everything It ...

The FDA cleared an Investigational New Drug (IND) application for RiboX Therapeutics' RXIM002, the first circular RNA-based in vivo CAR-T therapy for autoimmune cytopenias, marking a structural regulatory signal supporting next-generation cell therapy. This clearance challenges existing CAR-T trial design paradigms as RXIM002's in vivo manufacturing approach requires new patient stratification and protocol considerations outside conventional ex vivo CAR-T frameworks.

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