YONGIN, South Korea, March 12, 2025 /PRNewswire/ — GC Cell (KRX:144510), under the leadership of CEO Sungyong Won, announced today 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.”
About GC Cell
GC Cell is a pioneering biopharmaceutical company dedicated to developing innovative cellular therapies for the treatment of hematologic malignancies and other challenging diseases. With a focus on next‑generation immuno‑oncology, GC Cell is committed to addressing significant unmet medical needs through cutting‑edge research and strategic global partnerships.
Check out our AAV CDMO service to expedite your gene therapy research
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
Related News
Nanoscope Therapeutics Publishes Breakthrough Clinical Data Demonstrating Significant Vision Restoration in Retinitis Pigmentosa with Novel AAV-based MCO-010 Gene Therapy
Nanoscope Therapeutics has announced the publication of highly encouraging Phase 1/2a clinical trial data in the esteemed journal Molecular Therapy, showcasing significant vision restoration in patients suffering from retinitis pigmentosa (RP), a debilitating...
Capsida’s AAV CAP-004 Gene Therapy Shows Promise for Friedreich’s Ataxia in Primate Study at MDA Conference
Capsida Biotherapeutics' experimental gene therapy, CAP-004, for Friedreich's ataxia (FA), has demonstrated promising preclinical results in nonhuman primates. Research presented by Capsida at the 2025 MDA Clinical & Scientific Conference showed that a single...
FDA Grants Fast Track to Sanofi’s Chlamydia mRNA Vaccine
Sanofi is making significant strides in the fight against chlamydia, the most common sexually transmitted bacterial infection, for which there are currently no approved preventative vaccines. The French pharmaceutical group has recently been granted a fast-track...
Epicrispr Biotechnologies Announces $68M Series B to Advance First-in-Class FSHD Epigenetic Therapy to Clinic
Epicrispr Biotechnologies today announced the first close of its Series B financing, securing $68 million to support the clinical development of EPI-321, a first-in-class, disease-modifying therapy for facioscapulohumeral muscular dystrophy (FSHD), a genetic...
Related Services
AAV Packaging Services
READ MORE
Off-the-Shelf AAV Products
READ MORE
