GC Cell Begins First Patient Dosing in Phase 1 Trial for GCC2005 T-Cell Lymphoma Therapy

YONGIN, South Korea, March 12, 2025 — GC Cell, listed under KRX:144510 and led by CEO Sungyong Won, has initiated a domestic Phase 1 clinical trial for GCC2005, a pioneering CD5 CAR-NK cell therapy. This significant milestone, marked by the "first patient dosing," is a key development in the company’s partnership with Artiva Biotherapeutics, focusing on treatments for relapsed or refractory NK and T-cell malignancies.

GCC2005 is designed to address a critical need in oncology, particularly in treating T-cell lymphomas. These malignancies typically originate in extranodal lymphoid tissues and are known for their aggressive nature and poor prognosis compared to B-cell lymphomas, with fewer treatment options available.

To broaden the scope of NK-cell therapies, GCC2005 utilizes allogeneic cell therapy processes, employing NK cells derived from umbilical cord blood. These cells are engineered to target the CD5 marker, a molecule prominently expressed on T-cell lymphomas. By co-expressing a chimeric antigen receptor (CAR) with interleukin-15 (IL-15), GCC2005 aims to enhance NK cells' persistence and anti-tumor efficacy, addressing the common limitations found in traditional NK-cell therapies.

The ongoing Phase 1 trial, registered under ClinicalTrials.gov Identifier NCT06699771, plans to enroll around 48 participants diagnosed with relapsed or refractory NK and T-cell malignancies. The study’s main objectives are to assess GCC2005’s safety and tolerability, determine the maximum tolerated dose (MTD), and identify the recommended Phase 2 dose (RP2D).

Dr. Won Seog Kim from Samsung Medical Center, the lead investigator, emphasized the importance of this trial, stating, “The start of this Phase 1 trial is a significant leap forward in expanding treatment options for patients suffering from T-cell lymphomas. With the first patient dosing, we hope to contribute to the progress of CAR-NK therapies and broaden this emerging treatment scope.”

Last year, preclinical efficacy data was presented at the American Association for Cancer Research (AACR) and the T Cell Lymphoma Forum (TCLF), showcasing GCC2005’s capability to effectively eradicate tumor cells and improve in vivo persistence. These promising results have heightened expectations that GCC2005 might become a first-in-class therapeutic option globally for T-cell lymphoma. The therapy has also been recognized for its innovative potential by a Korea Drug Development Fund program, which aims to promote global market entry and forge strategic partnerships in drug development.

A representative from GC Cell expressed enthusiasm about the trial, stating, “Building on our strong preclinical results, we are thrilled to begin the Phase 1 clinical trial of GCC2005. This trial represents a crucial step toward offering a novel treatment option for patients with relapsed or refractory NK and T-cell malignancies. Our collaboration with Artiva Biotherapeutics and the recognition from national support programs affirm our dedication to advancing groundbreaking therapies in this difficult area.”

GC Cell stands as a leading biopharmaceutical firm devoted to developing innovative cellular therapies for hematologic malignancies and other challenging diseases. The company emphasizes next-generation immuno-oncology and is committed to addressing significant unmet medical needs through advanced research and strategic global partnerships.