One step closer to treating patients with relapsed/refractory lymphoma... GC Cell launches Phase 1b trial

[Financial News] A homegrown CAR-NK cell therapy has moved one step closer to treating patients with refractory T-cell lymphoma, for which there had been no suitable treatment other than chemotherapy for decades.
GC Cell said on the 7th that it had completed dosing in the dose-escalation phase of the Phase 1a trial of its drug candidate GCC2005 (CD5 CAR-NK), launched the Phase 1b trial and completed dosing of the first participant.
The Phase 1b trial will evaluate safety and tolerability, among other factors, in patients with NK-cell and T-cell lymphoma whose disease has relapsed or failed to respond to treatment following standard therapy. After optimizing the treatment regimen and dosage, the company plans to enroll additional patients in the optimal-dose cohort to strengthen the safety and efficacy data, then use the results to finalize the recommended Phase 2 dose (RP2D), which will form the basis for a global registrational trial. To accelerate the trial, the company plans to expand the number of domestic clinical trial sites to as many as six.
The efficacy of chemotherapy (CHOP), the standard first-line treatment for NK-cell and T-cell lymphoma, is limited, while second-line treatment is used only to a limited extent in some subtypes, leaving a significant unmet need for new treatment options. An estimated 20,000 people worldwide are newly diagnosed with T-cell lymphoma each year. Patients with relapsed or refractory disease have even fewer treatment options and a poor prognosis, making it a hard-to-treat blood cancer.
The Phase 1 trial of GCC2005 is currently focused on patients who have received multiple prior treatments. GC Cell is also considering the possibility of advancing into second-line treatment, an earlier stage of care. Its strategy is to broaden the scope of development to offer effective treatment opportunities earlier and increase the potential to improve patient survival.
GCC2005 is a fourth-generation allogeneic CAR-NK cell therapy designed to target CD5, which is predominantly expressed in T-cell lymphoma, and is being developed with the goal of becoming a global first-in-class therapy. It is designed to co-express interleukin-15 (IL-15), a feature intended to increase the persistence of immune cells in the body.
GC Cell evaluated the safety and preliminary efficacy of GCC2005 during the dose-escalation phase of the Phase 1a trial. The results were presented orally at a series of major international conferences last year, including the American Society of Hematology (ASH), the world’s largest hematology conference. At the recently held International Congress of BMT (ICBMT 2026), the company also presented a long-term follow-up case in which complete remission (CR) was achieved after a low dose and maintained for at least 18 months.
“Having confirmed GCC2005’s potential as a next-generation cell therapy in Phase 1a, we prepared for Phase 1b without disruption and completed dosing of the first patient,” said Won Seong-yong, CEO of GC Cell. “We will move ahead quickly with Phase 1b and do everything possible to prepare for a global registrational trial, so that GCC2005 can prove its value as a first-in-class therapy on the global stage in T-cell lymphoma, where unmet medical need is high.”
[email protected] Reporter Jeong Myeong-jin