July 15, 2025 – GenomeFrontier Therapeutics today announced promising early results from the ongoing Phase I clinical trial for its autologous CAR T cell therapy GF-CART01. The first patient treated with GF-CART01 achieved a complete metabolic response, as PET imaging showed no detectable tumor one month after the CAR T cell infusion.
GF-CART01 is an armored cell therapy with multiplex gene design intended for treatment of relapsed or refractory B cell malignancies. The dual-targeting CD19- and CD20-directed autologous CAR T cell therapy also incorporates a modulator to further improve its therapeutic function. The therapy was developed with the qCART™ platform, an implementation of GenomeFrontier’s Quantum Engine™ technology for production of CAR T cell therapies. Quantum Engine™ is a proprietary next-generation virus-free engineering platform for gene and cell therapies. Compared to conventional virus-based systems, the qCART™ platform offers enhanced gene delivery, improved safety, and significant reductions in manufacturing costs.
The ongoing clinical trial for GF-CART01 is being conducted in Taiwan at National Taiwan University Hospital. GenomeFrontier received IND approval from the Taiwan FDA in February 2025, completed GTP inspection in March, and initiated patient enrollment in April. The first patient received CAR T cell infusion in June, and PET imaging one month after the infusion confirmed a complete metabolic response. The Phase 1 study is intended to assess safety and manufacturing feasibility.
The initial therapeutic outcome prompted Dr. Sareina Wu, Founder of GenomeFrontier, to comment “This clinical result marks a significant milestone in our development journey and reinforces our confidence in the clinical applicability of our virus-free CAR T platform. We look forward to further results from this trial and remain committed to providing cures for patients with devasting diseases.”
For more information about the clinical trial, please visit: https://genomefrontier.com/clinical -trial/