GC Cell announced that its developing CD5-targeted chimeric antigen receptor natural killer (CAR-NK) cell therapy, GCC2005, has received approval for therapeutic use from the Ministry of Food and Drug Safety on September 18.
The approval was requested by Seoul National University Hospital, targeting patients with peripheral T-cell lymphoma who have limited treatment options after receiving prior therapies. The hospital plans to administer the investigational drug GCC2005 to these patients for therapeutic purposes.
The therapeutic use approval system allows for the exceptional use of investigational drugs that have not yet received formal approval for patients in critical condition or with no alternative treatment options.
GCC2005 is a candidate for a first-in-class CD5-targeted allogeneic CAR-NK cell therapy that GC Cell is developing as a key part of its pipeline.
CAR-NK therapy involves genetically modified natural killer (NK) cells that are designed to recognize specific antigens on cancer cells and attack them. The therapy has completed dosing for patients in the domestic Phase 1a trial and is preparing to initiate Phase 1b.
The treatment will be led by Professor Byeon Ja-min of the Department of Hematology and Oncology at Seoul National University Hospital. Professor Byeon is directly involved in the domestic Phase 1 trial of GCC2005 and possesses expertise and clinical experience in the mechanisms of action and treatment of T-cell and NK lymphomas.
A representative from GC Cell stated, "We are now able to provide the opportunity to administer GCC2005 to patients whose conditions are urgent and have limited treatment alternatives, making it difficult to wait for participation in Phase 1b. We will continue to advance the clinical development and global strategy for GCC2005."
* This article has been translated by AI.
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