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CD19-1XX CAR is an investigational in vivo CAR-T cell therapy being developed by Alaya.bio (originally initiated by Ixaka as CELTIC-19) for the treatment of oncology and autoimmune diseases. The therapy utilizes Alaya.bio's proprietary targeting polymeric nanoparticle platform, which consists of a biodegradable polymer-coated lentiviral vector grafted with a CD3-targeting agent. Upon a single intravenous infusion, the nanoparticles selectively target and transduce circulating T cells in vivo, delivering a CD19-directed CAR transgene. The CAR construct incorporates a calibrated 1XX signaling module (a modified CD28/CD3ζ signaling domain with mutated ITAMs) designed to provide potent effector function and extended persistence with reduced T-cell exhaustion and lower toxicity. This in vivo approach bypasses the complex, costly, and time-consuming ex vivo manufacturing process of traditional CAR-T therapies.
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