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**KXV01 TCR Lentinvivo** is a third-generation non-replicative self-inactivating lentiviral vector designed for in vivo gene therapy in advanced solid tumors. It delivers patient-derived personalized tumor-reactive T-cell receptors (TCRs) directly into the patient's T cells to enable them to recognize and attack tumor neoantigens, bypassing HLA restrictions and standard ex vivo cell manipulation. Developed as an investigator-initiated therapy, it is being evaluated in a phase 1 dose-escalation trial (NCT07196579) using a BOIN design to assess safety, tolerability (including dose-limiting toxicities like CRS and ICANS), and preliminary efficacy in patients with incurable or metastatic solid tumors refractory to standard treatments.[1][2][5]
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