GC Cell Launches Phase 1 Clinical Trial for GCC2005, a Novel CD5 CAR-NK Therapy Targeting T-Cell Lymphomas

13 March 2025 | Thursday | News

Under CEO Sungyong Won's leadership, GC Cell announces the first patient dosing of GCC2005, a promising new treatment for relapsed or refractory NK and T-cell malignancies, in collaboration with Artiva Biotherapeutics.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

GC Cell, under the leadership of CEO Sungyong Won, announced the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB‑205), a novel CD5 CAR‑NK cell therapy. This "first patient dosing" marks a critical milestone in the company's collaboration with its ex-APAC partner Artiva Biotherapeutics, as we advance the development of this innovative treatment targeting relapsed or refractory NK and T‑cell malignancies.

With GCC2005, GC Cell is striving to fulfill a significant unmet need in oncology. T‑cell lymphomas, which often arise in extranodal lymphoid tissues, are highly aggressive and generally exhibit a poorer prognosis than their B‑cell counterparts with limited treatment options.

Aimed at expanding possibilities for NK‑cell therapies, GCC2005 is an allogeneic cell therapy product manufactured using umbilical cord blood–derived NK cells. Engineered to target the CD5 marker—which is highly expressed on T‑cell lymphomas—GCC2005 co‑expresses a chimeric antigen receptor (CAR) alongside interleukin‑15 (IL‑15). This dual expression is designed to enhance the persistence and anti‑tumor efficacy of NK cells—effectively addressing a common limitation of conventional NK-cell therapies.

The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT06699771) will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T‑cell malignancies. The primary objectives of the study are to evaluate the safety and tolerability of GCC2005, the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D).

"The initiation of this Phase 1 trial marks a significant step toward expanding treatment options for patients with T-cell lymphomas," said Dr. Won Seog Kim of Samsung Medical Center, the lead investigator of the study. "With this first patient dosing, we anticipate contributing to both the advancement of CAR-NK therapies and the expansion of this emerging treatment landscape."

Preclinical efficacy data presented last year at the American Association for Cancer Research (AACR) and the T Cell Lymphoma Forum (TCLF) highlighted GCC2005's potent ability to kill tumor cells and improve in vivo persistence. These promising results have bolstered expectations that GCC2005 could become a global first‑in‑class therapeutic option for T‑cell lymphoma. In recognition of its innovative potential, GCC2005 has also been selected by a Korea Drug Development Fund program aimed at promoting global market entry and strategic partnerships in drug development.

"Building on our robust preclinical results, we are excited to commence the Phase 1 clinical trial of GCC2005. This study represents an important step toward providing a new treatment option for patients with relapsed or refractory NK and T‑cell malignancies," 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."

Survey Box

Poll of the Week

Which area of biopharmaceutical research excites you the most?

× Please select an option to participate in the poll.
Processing...
× You have successfully cast your vote.
 {{ optionDetail.option }}  {{ optionDetail.percentage }}%
 {{ optionDetail.percentage }}% Complete
More polls
Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

© 2025 Biopharma Boardroom. All Rights Reserved.

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close