GC Cell to Present Interim Results of 'CD5 CAR-NK Therapy' Clinical Trial at ASH 2025

Objective Response Rate of 60% and Safety Confirmed

GC Cell announced on November 4 that the interim results of the Phase 1a clinical trial for its investigational CD5 CAR-NK cell therapy, 'GCC2005', have been selected for an oral presentation at the 67th American Society of Hematology (ASH 2025) Annual Meeting.

GC Cell

This presentation will take place during the "Early Clinical Trials and Toxicity of Cellular Therapy" session at ASH 2025, which will be held in Orlando, Florida, on December 8 (local time). Professor Kim Wonseok of the Department of Hematology and Oncology at Samsung Medical Center will deliver the presentation.

GCC2005 is an allogeneic umbilical cord blood-derived CAR-NK cell therapy targeting CD5. Its key features include enhanced antitumor activity through CAR gene introduction and improved in vivo cell persistence via IL-15 expression. The upcoming presentation will cover interim results from the first domestic Phase 1a clinical study targeting patients with relapsed or refractory NK and T-cell lymphomas.

The abstract includes data from two low-dose cohorts out of a total of four dose levels, with a cutoff date of August 5. A total of seven patients with CD5-positive relapsed or refractory NK/T-cell lymphoma were enrolled, and these patients had received an average of three or more prior treatments. Initial safety assessments for the seven patients showed no dose-limiting toxicity, no serious adverse events, and no cases of immune cell-associated neurotoxicity syndrome or graft-versus-host disease, which are fatal side effects of cell therapy.

Additionally, tumor evaluation results for five patients showed an objective response rate (ORR) of 60%. Among them, two achieved complete response (CR) and one achieved partial response (PR). Notably, there was a reported case of complete response after a single administration, demonstrating the therapy's antitumor potential.

GC Cell is currently conducting cohort studies at higher dose levels and plans to expand to a domestic Phase 1b and global Phase 2 clinical trials based on the results of the Phase 1a study.

GC Cell CEO Won Sungyong stated, "This oral presentation at ASH is a significant achievement that demonstrates the scientific rationale and clinical potential of GCC2005 on an international stage. Building on our innovative cell therapy technology and platform, GC Cell will continue to advance the development of next-generation immunotherapy, global clinical trials, and partnerships."

This content was produced with the assistance of AI translation services.