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ORGCAR19 is an autologous CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy being developed by Orgenesis for the treatment of relapsed or refractory B‑cell acute lymphoblastic leukemia (B‑ALL) and B‑cell lymphomas. It uses patient-derived T lymphocytes that are genetically modified ex vivo with a third‑generation lentiviral vector encoding a monomeric anti‑CD19 CAR, then expanded and reinfused to selectively recognize and eliminate CD19‑expressing malignant B cells. Orgenesis is pursuing a decentralized, point‑of‑care manufacturing model for ORGCAR19 under license from Kecellitics, aiming to reduce production costs and broaden access to CAR‑T therapies while maintaining high response rates and a comparatively low incidence of severe cytokine release syndrome in early real‑world experience.
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