Drug administered to refractory peripheral T-cell lymphoma patients with no other options
Next-generation pipeline completes domestic Phase 1a trial, prepares for Phase 1b
Fourth-generation allogeneic CAR-NK therapy co-expresses IL-15 to overcome treatment limits
GC Cell's allogeneic immune cell therapy candidate, developed in-house, has received compassionate use approval from the Ministry of Food and Drug Safety and will be administered on an emergency basis to patients with refractory blood cancer.
GC Cell announced Friday that GCC2005 — its CD5-targeting chimeric antigen receptor natural killer (CAR-NK) cell therapy — had obtained compassionate use approval from the Ministry of Food and Drug Safety.
Compassionate use approval is a regulatory mechanism that allows investigational drugs still in development to be administered on an exceptional basis to critically ill or terminally ill patients who have no alternative treatment options. The approval came after Seoul National University Hospital applied on behalf of peripheral T-cell lymphoma patients who had exhausted existing therapies and had no remaining options.
GCC2005 is GC Cell's lead new drug candidate, targeting first-in-class status globally. It is a fourth-generation allogeneic CAR-NK cell therapy engineered to target CD5, a protein predominantly expressed in T-cell lymphoma, and is precisely designed to co-express interleukin-15 (IL-15) to enhance the persistence of immune cells in the body. The company has completed dosing for all patients in the domestic Phase 1a trial and is preparing to enter Phase 1b.
Byun Ja-min, a professor in the Division of Hematology and Oncology at Seoul National University Hospital, is leading the administration and serves as the principal investigator for the domestic Phase 1 trial of GCC2005. She has built clinical expertise in T-cell and NK lymphoma.
The Ministry of Food and Drug Safety approval is significant because, despite GCC2005 being an early-stage investigational compound, regulators recognized its safety and potential efficacy and authorized its use in actual patient care for refractory T-cell lymphoma patients who have no treatment options available in the clinic.
"Patients with refractory T-cell lymphoma who have failed standard treatment have extremely limited options," Byun said. "I hope this administration will give patients a meaningful opportunity for treatment."
A GC Cell official said the company was "providing a treatment opportunity to patients too critically ill to wait for subsequent clinical trials" and added that it would "support the dosing process in collaboration with the Seoul National University Hospital research team while continuing its clinical development and global expansion strategy."
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