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OTX-201
- Development stage
- Unknown
- Lead developer
- Orbital Therapeutics
- Modality
- CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, RNA Therapeutics → Nucleic Acid Therapeutics, Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Administration
- Intravenous
01
Overview
OTX-201 is an investigational in vivo CAR-T cell therapy designed for the treatment of B cell-driven autoimmune diseases. It utilizes an optimized circular RNA that encodes a CD19-targeted chimeric antigen receptor (CAR), delivered via targeted lipid nanoparticles (LNPs) for direct in vivo administration. OTX-201 aims to deplete autoreactive B cells by reprogramming the patient’s immune cells inside the body to express a CAR that targets CD19, a marker found on B cells. This approach is intended to reset the immune system in autoimmune disorders, offering a potentially simpler, safer, and more accessible alternative to conventional ex vivo CAR-T therapies, which require complex manufacturing and hospitalization. Orbital Therapeutics initially developed OTX-201, and as of October 2025, the company has been acquired by Bristol Myers Squibb[1][3][6].
- Other names
- OTX-201OTX201OTX 201In vivo expression of CARs (Orbital)
02
Targets
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