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GC Cell Doses First Patient in Phase 1 Trial of Novel CD5 CAR-NK Cell Therapy for T-Cell Lymphoma

• GC Cell has initiated first patient dosing in a Phase 1 clinical trial of GCC2005, a novel CD5 CAR-NK cell therapy targeting relapsed or refractory NK and T-cell malignancies, addressing a significant unmet need in aggressive lymphomas.

• The innovative therapy utilizes allogeneic umbilical cord blood-derived NK cells engineered with a CD5-targeting chimeric antigen receptor and IL-15 co-expression to enhance persistence and anti-tumor efficacy.

• The trial will enroll approximately 48 patients to evaluate safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose, with promising preclinical data suggesting potential as a first-in-class treatment option.

GC Cell (KRX:144510) announced today the initiation of patient dosing in its Phase 1 clinical trial for GCC2005 (AB-205), a novel CD5 CAR-NK cell therapy targeting relapsed or refractory NK and T-cell malignancies. This milestone marks significant progress in the company's collaboration with Artiva Biotherapeutics, its partner outside the Asia-Pacific region.
T-cell lymphomas represent a significant unmet medical need in oncology. These aggressive malignancies, which frequently develop in extranodal lymphoid tissues, generally have poorer prognoses than B-cell lymphomas and limited treatment options for patients who relapse or become refractory to initial therapies.

Innovative Dual-Expression Technology

GCC2005 represents an advancement in NK-cell therapy design. The allogeneic cell therapy is manufactured using umbilical cord blood-derived natural killer cells engineered to target CD5, a marker highly expressed on T-cell lymphomas. What distinguishes this approach is the co-expression of a chimeric antigen receptor (CAR) alongside interleukin-15 (IL-15).
"This dual expression system directly addresses one of the primary limitations of conventional NK-cell therapies," explained a GC Cell representative. "By enhancing both persistence and anti-tumor efficacy of the NK cells, we aim to create a more durable therapeutic response."

Phase 1 Trial Design and Objectives

The ongoing Phase 1 trial (NCT06699771) will enroll approximately 48 patients diagnosed with relapsed or refractory NK and T-cell malignancies. According to the clinical protocol, investigators will primarily assess:
  • Safety and tolerability of GCC2005
  • Maximum tolerated dose (MTD)
  • Recommended Phase 2 dose (RP2D)
Dr. Won Seog Kim of Samsung Medical Center, the lead investigator of the study, emphasized the significance of this development: "The initiation of this Phase 1 trial marks a significant step toward expanding treatment options for patients with T-cell lymphomas. With this first patient dosing, we anticipate contributing to both the advancement of CAR-NK therapies and the expansion of this emerging treatment landscape."

Promising Preclinical Results

The clinical trial follows encouraging preclinical data presented at both the American Association for Cancer Research (AACR) and the T Cell Lymphoma Forum (TCLF) last year. These studies demonstrated GCC2005's potent ability to kill tumor cells and improve in vivo persistence.
These results have generated considerable optimism that GCC2005 could potentially become a global first-in-class therapeutic option for T-cell lymphoma. The therapy's innovative approach has also garnered recognition from the Korea Drug Development Fund, which selected GCC2005 for a program aimed at promoting global market entry and strategic partnerships in drug development.

Addressing a Critical Treatment Gap

T-cell lymphomas account for approximately 10-15% of all non-Hodgkin lymphomas but have historically received less research attention than their B-cell counterparts. Patients with relapsed or refractory disease face particularly poor outcomes with current standard therapies.
Sungyong Won, CEO of GC Cell, stated, "Our commitment to addressing significant unmet needs in oncology drives our development of innovative cellular therapies like GCC2005. This trial represents an important step in our mission to provide new treatment options for patients with limited alternatives."

Strategic Collaboration

The development of GCC2005 highlights the importance of strategic partnerships in advancing novel cell therapies. GC Cell's collaboration with Artiva Biotherapeutics combines complementary expertise and resources to accelerate the clinical development process.
"Building on our robust preclinical results, we are excited to commence the Phase 1 clinical trial of GCC2005," said a GC Cell representative. "Our collaboration with Artiva Biotherapeutics and the recognition received through national support programs further validate our commitment to advancing breakthrough therapies in this challenging area."
As the trial progresses, GC Cell will continue to evaluate the therapy's potential to address the significant unmet needs of patients with these aggressive hematologic malignancies.
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