Sleeping Beauty TCR-T cells

Sleeping Beauty TCR-T cells are autologous T cell therapies genetically engineered using the non-viral Sleeping Beauty transposon system to express tumor-specific or mutation-specific T cell receptors (TCRs). This approach enables the redirection of a patient's own immune system to recognize and attack cancer cells expressing shared driver mutations such as KRAS and TP53. The therapy is being developed primarily for solid tumors including non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, endometrial cancer, ovarian cancer, and bile duct cancers. The manufacturing process involves electroporation of patient-derived peripheral blood mononuclear cells with plasmids encoding both the desired TCR and the transposase enzyme. Early clinical data from phase 1/2 trials demonstrate a manageable safety profile with signs of efficacy in heavily pretreated patients with refractory solid tumors. Alaunos Therapeutics is leading development efforts in collaboration with academic centers such as MD Anderson Cancer Center. The Sleeping Beauty platform uses a non-viral gene transfer method that may offer advantages in cost-effectiveness and manufacturing scalability compared to viral vector-based approaches. The ongoing phase 1/2 trial (NCT05194735) is actively enrolling patients across multiple solid tumor types expressing high-frequency driver mutations. Persistence of engineered T cells has been observed up to six months post-infusion in some patients.

Other names

Sleeping Beauty TCR-T therapySB TCR-T cellsSleeping Beauty system TCR-T cells