{"id":19833,"date":"2025-03-13T08:15:50","date_gmt":"2025-03-13T08:15:50","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/gc-cell-initiates-first-patient-dosing-in-phase-1-clinical-trial-for-gcc2005-a-promising-t%e2%80%91cell-lymphoma-cd5-car-nk-therapy\/"},"modified":"2025-03-13T08:15:50","modified_gmt":"2025-03-13T08:15:50","slug":"gc-cell-initiates-first-patient-dosing-in-phase-1-clinical-trial-for-gcc2005-a-promising-t%e2%80%91cell-lymphoma-cd5-car-nk-therapy","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=19833","title":{"rendered":"GC Cell Initiates First Patient Dosing in Phase 1 Clinical Trial for GCC2005, a Promising T\u2011Cell Lymphoma CD5 CAR-NK Therapy"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

YONGIN, South Korea<\/span><\/span>, March 13, 2025<\/span><\/span> \/PRNewswire\/ — GC Cell (KRX:144510), under the leadership of CEO Sungyong Won<\/span>, announced today the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB\u2011205), a novel CD5 CAR\u2011NK 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\u2011cell malignancies.<\/p>\n

\n<\/div>\n

With GCC2005, GC Cell is striving to fulfill a significant unmet need in oncology. T\u2011cell lymphomas, which often arise in extranodal lymphoid tissues, are highly aggressive and generally exhibit a poorer prognosis than their B\u2011cell counterparts with limited treatment options.<\/p>\n

Aimed at expanding possibilities for\u00a0NK\u2011cell therapies, GCC2005 is an allogeneic cell therapy product manufactured using umbilical cord blood\u2013derived NK cells. Engineered to target the CD5 marker\u2014which is highly expressed on T\u2011cell lymphomas\u2014GCC2005 co\u2011expresses a chimeric antigen receptor (CAR) alongside interleukin\u201115 (IL\u201115). This dual expression is designed to enhance the persistence and anti\u2011tumor efficacy of NK cells\u2014effectively addressing a common limitation of conventional NK-cell therapies.<\/p>\n

The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT06699771) will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T\u2011cell 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).<\/p>\n

“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<\/span> 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.”<\/p>\n

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\u2011in\u2011class therapeutic option for T\u2011cell 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.<\/p>\n

“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\u2011cell 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.”<\/span><\/p>\n

About GC Cell<\/b><\/p>\n

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\u2011generation immuno\u2011oncology, GC Cell is committed to addressing significant unmet medical needs through cutting\u2011edge research and strategic global partnerships.<\/span><\/p>\n

For further information, please contact:<\/p>\n

Jabin Yun<\/span><\/b>
Team Lead, Communication Team, GC Cell
jabin.yun@gccorp.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

YONGIN, South Korea<\/span><\/span>, March 13, 2025<\/span><\/span> \/PRNewswire\/ — GC Cell (KRX:144510), under the leadership of CEO Sungyong Won<\/span>, announced today the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB\u2011205), a novel CD5 CAR\u2011NK 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\u2011cell malignancies.<\/p>\n

\n<\/div>\n

With GCC2005, GC Cell is striving to fulfill a significant unmet need in oncology. T\u2011cell lymphomas, which often arise in extranodal lymphoid tissues, are highly aggressive and generally exhibit a poorer prognosis than their B\u2011cell counterparts with limited treatment options.<\/p>\n

Aimed at expanding possibilities for\u00a0NK\u2011cell therapies, GCC2005 is an allogeneic cell therapy product manufactured using umbilical cord blood\u2013derived NK cells. Engineered to target the CD5 marker\u2014which is highly expressed on T\u2011cell lymphomas\u2014GCC2005 co\u2011expresses a chimeric antigen receptor (CAR) alongside interleukin\u201115 (IL\u201115). This dual expression is designed to enhance the persistence and anti\u2011tumor efficacy of NK cells\u2014effectively addressing a common limitation of conventional NK-cell therapies.<\/p>\n

The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT06699771) will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T\u2011cell 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).<\/p>\n

“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<\/span> 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.”<\/p>\n

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\u2011in\u2011class therapeutic option for T\u2011cell 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.<\/p>\n

“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\u2011cell 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.”<\/span><\/p>\n

About GC Cell<\/b><\/p>\n

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\u2011generation immuno\u2011oncology, GC Cell is committed to addressing significant unmet medical needs through cutting\u2011edge research and strategic global partnerships.<\/span><\/p>\n

For further information, please contact:<\/p>\n

Jabin Yun<\/span><\/b>
Team Lead, Communication Team, GC Cell
jabin.yun@gccorp.com<\/a><\/p>\n

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