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GCC2005: Breakthrough CAR-NK Therapy Shows 62.5% Response Rate in Clinical Trial

HealthGCC2005: Breakthrough CAR-NK Therapy Shows 62.5% Response Rate in Clinical Trial
/ GC Cell
/ GC Cell

GC Cell announced on Monday that interim results from the Phase 1a clinical trial of GCC2005 (CD5 CAR-NK) were presented at ICBMT 2026 on September 17.

The company has been consistently sharing clinical outcomes for GCC2005 at major international conferences, includingAmerican Society of Hematology (ASH) 2025.

The presentation highlighted GCC2005’s development process and interim results from the Phase 1a trial in patients with relapsed or refractory NK/T-cell lymphoma. It also unveiled early research findings, including the rationale behind the CD5 target selection, CAR construct development, and GCC2005’s in vitro and in vivo analysis results.

As of October 31, 2025, nine patients were enrolled in the study. Among the eight patients eligible for tumor assessment, the objective response rate (ORR) was 62.5%, with three achieving complete remission (CR) and two showing partial remission (PR). Initial safety evaluations reported no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD).

A notable long-term follow-up case was presented involving a patient with angioimmunoblastic T-cell lymphoma (AITL) who had relapsed after three prior treatments. This patient achieved complete remission following low-dose administration and has maintained it for 18 months. Another striking case involved a patient with initially prominent tumor lesions who experienced rapid tumor disappearance and reached complete remission shortly after treatment.

The International Conference on Blood and Marrow Transplantation (ICBMT), organized by the Korean Society for Blood and Marrow Transplantation (KSBMT), is a global forum for sharing cutting-edge research in hematologic diseases, including hematopoietic stem cell transplantation and cell and gene therapies. This year’s conference was held from September 17-19 at BEXCO in Busan, South Korea.

GCC2005, GC Cell’s flagship pipeline product, is a CD5-targeted allogeneic CAR-NK cell therapy candidate being developed as a potential first-in-class global innovative drug. The company has completed patient dosing for the Phase 1a trial in South Korea and is gearing up to launch the Phase 1b trial.

CAR-NK therapy employs genetically modified natural killer (NK) cells designed to recognize specific targets on cancer cells, enabling them to mount an attack against these malignant cells.

Won Seong-yong, Chief Executive Officer (CEO) of GC Cell, stated that they’re continuously presenting GCC2005’s clinical results at major international conferences and engaging in discussions with experts about their clinical significance. It’s committed to advancing the Phase 1b trial as planned and progressing towards global registration trials.

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