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Alaunos Therapeutics Begins Study of Autologous Cell Therapy Using Non-Viral Gene Transfer

NEW YORK – Alaunos Therapeutics on Monday said it has dosed the first patient in its Phase I/II trial evaluating its autologous TCR-T cell therapy for solid tumor patients harboring KRAS, TP53, or EGFR mutations. 

The Houston-based firm will enroll around 180 patients with advanced, previously treated non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers in the first-in-human trial taking place at the University of Texas MD Anderson Cancer Center. Study participants will receive autologous T cells engineered using Alaunos' non-viral Sleeping Beauty transposon/transposase gene transfer system to express T-cell receptors (TCRs) targeting hotspot neoantigens. 

To be eligible for the trial, patients must have specific human leukocyte antigen types and hotspot mutations that are targeted by one of the T-cell receptors in Alaunos' library. 

The study is designed to evaluate the treatment's safety and recommended Phase II dose as well as preliminary efficacy and the feasibility of manufacturing these autologous cell therapies — a process that Houston-based Alaunos is conducting in its new in-house facility. Alaunos — which changed its name from Ziopharm Oncology in January — expects to report initial data from the trial during the second half of this year. 

"This is a significant accomplishment as the first-in-human dosing of a patient with Sleeping Beauty TCR-T cells," Carl June, chairman of the firm's scientific advisory board, said in a statement. "This approach targeting shared driver mutations that are at the core of cancer provides hope of meaningful clinical responses."