GC Cell announced on Sept. 18 that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved the compassionate use of its investigational cell therapy candidate GCC2005 (CD5 CAR-NK) for a patient suffering from refractory peripheral T-cell lymphoma at Seoul National University Hospital.
The authorization follows an application submitted by Seoul National University Hospital to administer the investigational treatment to a patient facing limited alternative options after failing standard therapies. Under South Korea's compassionate use framework, unapproved experimental drugs in clinical development can be administered on an exceptional basis to patients with severe or end-stage diseases when no alternative treatments exist.
Formed in 2021 through the merger of GC Green Cross LabCell and GC Green Cross Cell, GC Cell previously commercialized the anticancer immune cell therapy Immuncell-LC Inj. and is currently developing next-generation platforms, including CAR-NK therapies. GCC2005 is an allogeneic CD5-targeting CAR-NK cell therapy engineered to attack CD5 markers on T-cell lymphoma cells while co-expressing interleukin-15 (IL-15) to prolong immune cell survival within the body.
The company recently completed patient dosing in a domestic Phase 1a trial and is preparing to initiate Phase 1b. Interim Phase 1a results disclosed last year demonstrated an objective response rate (ORR) of 60%, with three out of five evaluable patients responding to the treatment—including two achieving a complete response (CR) and one achieving a partial response (PR).
“For patients with refractory T-cell lymphoma who have failed standard chemotherapy, treatment options are extremely limited,” said Byun Ja-min, a professor in the Division of Hematology-Oncology at Seoul National University Hospital who is leading the patient's care. “We hope this compassionate use approval will provide a meaningful therapeutic opportunity.”
A GC Cell official added, “We consider it deeply meaningful to offer GCC2005 to a patient whose medical condition is too urgent to wait for Phase 1b trial enrollment and who has exhausted existing options.”
