GC Cell Unveils Clinical Results of Next-Generation CD5 CAR-NK Therapy at ASH 2025

GC Cell announced that the interim results of the domestic Phase 1a dose-escalation trial (NCT06699771) for 'GCC2005,' an allogeneic umbilical cord blood-derived CAR-NK cell therapy targeting CD5 (a protein expressed on the surface of immune cells), were presented orally on December 8 (local time) at the 67th American Society of Hematology (ASH 2025) Annual Meeting held in Orlando, USA.

GCC2005 is an allogeneic umbilical cord blood-derived CAR-NK cell therapy targeting CD5. Currently, GCC2005 is undergoing a domestic Phase 1 clinical trial at Samsung Medical Center (Professor Kim Wonseok), Asan Medical Center (Professor Yoon Deokhyun), and Seoul National University Hospital (Professor Ko Youngil). ASH is the world’s largest hematology society, and the selection of GCC2005 for an oral presentation demonstrates the international attention its development is receiving.

This presentation covered the latest interim results updated as of October 31. The results were presented by Professor Kim Wonseok of Samsung Medical Center. A total of nine patients with relapsed or refractory NK/T-cell lymphoma were enrolled, all of whom were high-risk patients with a history of multi-line (an average of three or more) treatments.

Among the eight patients evaluable for tumor response, the objective response rate (ORR) was 62.5% (three complete responses and two partial responses). Considering that the typical response rate for existing anticancer drugs is below 30%, this is an encouraging figure. A trend of higher response rates with increased dosing was also observed. There was also a reported case where a complete response was achieved with just a single administration. In addition, among the three patients who experienced progressive disease (PD), two showed a reduction in the size of their target lesions.

This presentation also included a case in which a patient with T-cell lymphoma who had experienced repeated relapses maintained a complete response for more than six months after treatment.

To date, among all participants who have received the therapy, no dose-limiting toxicity (DLT) or serious adverse events have been observed, and no infection issues-previously raised with competing CD5 CAR-T cell therapies-have been detected so far.

The presentation attracted significant attention on site. After the presentation, Professor Kim Wonseok emphasized, "Platform technologies are rare in the Korean biotech industry, but GC Cell has achieved results based on over a decade of robust CAR-NK cell development capabilities. In particular, CD5 CAR-NK has a high potential to become a global first-in-class therapy, which raises expectations."

GC Cell stated that GCC2005 has demonstrated meaningful efficacy signals and a favorable safety profile in early clinical trials. The company is continuing to evaluate higher dose levels and, based on the results, plans to expand development into a Phase 1b (dose expansion) and a global Phase 2 trial.

GC Cell CEO Won Seongyong said, "This ASH oral presentation marks an important milestone in gaining international recognition for the early clinical achievements of GCC2005. We will accelerate global development and partnerships to provide new treatment options for patients with relapsed or refractory hematologic cancers."