GC Cell's (144510.KQ) CD5-targeting CAR-NK cell therapy GCC2005 will be used to treat patients with peripheral T-cell lymphoma who have few remaining options after standard treatment.
GC Cell said on the 18th that GCC2005 had received approval from the Ministry of Food and Drug Safety for compassionate use. Seoul National University Hospital filed the application on behalf of patients with peripheral T-cell lymphoma who have limited alternatives after prior treatment. The hospital plans to administer GCC2005, an investigational drug, to the patient for treatment purposes.
The compassionate use program allows investigational drugs that have not yet received approval from the drug ministry to be used in exceptional cases for patients with severe or terminal illness whose lives are at risk or for whom no alternative treatment exists.
GCC2005 is an allogeneic CD5-targeting CAR-NK cell therapy that GC Cell is developing as a potential first-in-class drug. The company has completed dosing in a Phase 1a trial in Korea and is preparing to begin the Phase 1b stage.
The treatment will be led by Byun Ja-min, a professor of hematology and oncology at Seoul National University Hospital. Byun is an investigator directly involved in the domestic Phase 1 trial of GCC2005 and has expertise and clinical experience in the drug's mechanism of action and in the treatment of T-cell and NK-cell lymphoma.
"Patients with refractory T-cell lymphoma who have failed standard chemotherapy have extremely limited treatment options," Byun said. "We hope this compassionate use will provide a meaningful treatment opportunity for the patient."
"We find it significant that we can offer GCC2005 to a patient whose condition is too urgent to wait for enrollment in the Phase 1b trial and whose treatment alternatives are limited," an official at GC Cell said. "We will continue to pursue clinical development of GCC2005 and our global development strategy."
