GC Cell Applies for Phase 1 Clinical Trials of Homologous CAR-NK Therapy 'AB-201' in Korea and Australia

GC Cell (GCsel) announced on the 17th that it has simultaneously submitted the Phase 1 clinical trial application (IND) for ‘AB-201,’ an allogeneic chimeric antigen receptor (CAR)-natural killer (NK) cell therapy targeting solid tumors, to the Korea Ministry of Food and Drug Safety and the Australian Human Research Ethics Committee (HREC).

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Photo by GC Cell

AB-201 is an off-the-shelf allogeneic CAR-NK cell therapy product, cryopreserved and equipped with a CAR targeting human epidermal growth factor receptor 2 (HER2), which is overexpressed in breast, ovarian, and gastric cancers, using umbilical cord blood-derived NK cells.

Through GC Cell’s proprietary core technology, AB-201 features an optimized CAR structure for NK cell activation and maximized in vivo persistence, demonstrating excellent cancer cell elimination and tumor suppression, including complete remission (CR) in animal models. Additionally, the unique HER2-targeting CAR was patented in Australia in 2022 and has been filed in five countries including the United States.

This clinical trial will be a multinational, open-label, dose-escalation and expansion Phase 1 study involving up to 48 patients with HER2-overexpressing solid tumors such as breast cancer, gastric cancer, and gastroesophageal junction cancer. The trial aims to evaluate the safety and some efficacy of AB-201 and establish the recommended Phase 2 dose (RP2D).

The company plans to conduct the first-in-human clinical trial of AB-201 simultaneously in Korea and Australia to secure high-quality clinical data across diverse ethnic groups. By selecting renowned Australian cancer institutions such as Peter MacCallum Cancer Centre, GC Cell intends to perform systematic and reliable clinical trials based on excellent medical systems and healthcare professional networks, thereby securing competitiveness in global markets including Europe and the United States.

The company also emphasized the significance of this being the first-in-human clinical trial of an allogeneic CAR-NK cell therapy using donor cells among domestic companies.

James Park, CEO of GC Cell, stated, “We aim to be the fastest globally to enter clinical trials in the HER2-targeting allogeneic CAR-NK cell therapy field. By applying GC Cell’s global-level cell and gene therapy (CGT) technology to the proven HER2-targeting mechanism in oncology, we will develop an allogeneic CGT that can be administered immediately when needed, dramatically increasing treatment opportunities and convenience for patients.”

This content was produced with the assistance of AI translation services.