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Sleeping Beauty TCR-T is an autologous, non-viral T-cell receptor (TCR) engineered T-cell therapy. It utilizes the Sleeping Beauty (SB) transposon/transposase system, a DNA-based gene transfer method, to introduce tumor-specific TCRs into a patient's T cells. This approach avoids the use of viral vectors (such as lentivirus or retrovirus), potentially reducing manufacturing complexity and cost. The therapy targets specific driver mutations (neoantigens) in genes such as KRAS, TP53, and EGFR, which are presented by specific Human Leukocyte Antigen (HLA) molecules on the surface of cancer cells. Developed through a collaboration between the National Cancer Institute (NCI) and Alaunos Therapeutics (formerly Ziopharm Oncology), it is currently being evaluated in Phase 1/2 clinical trials for various solid tumors, including colorectal, pancreatic, and non-small cell lung cancers.
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