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GC Cell starts Phase 1b trial of GCC2005 in T-cell lymphoma, first patient dosed
En breve
GC Cell said on Oct 7 that its drug candidate GCC2005 (CD5 CAR-NK), a cell therapy for T-cell lymphoma, has entered a Phase 1b trial and that the first subject has been dosed. The company completed the dose-escalation stage of Phase 1a and plans to use Phase 1b to settle dosing and gather more safety and efficacy data ahead of a global registrational trial.
Leer la noticia completa 2 min de lectura
GC Cell said on Oct 7 that GCC2005 (CD5 CAR-NK), its drug candidate for T-cell lymphoma, has entered a Phase 1b trial and that the first subject has been dosed. The company said it had completed the dose-escalation stage of the Phase 1a trial. [ 1 , 2 , 3 , 4 ]
In Phase 1b, the company said it will optimise the administration method and dose of GCC2005 and enrol additional patients in the optimal dose cohort to strengthen safety and efficacy data. On that basis it plans to determine the recommended Phase 2 dose to serve as the foundation for a future global registrational trial. To speed up development, GC Cell said it will add major domestic clinical trial institutions, expanding to as many as six sites. [ 2 , 4 ]
The trial enrols patients with NK/T-cell lymphoma that has relapsed after, or failed to respond to, standard treatment. GC Cell said chemotherapy (CHOP) has been the standard first-line treatment for decades with limited efficacy, and that second-line treatment is used only in a limited way in some subtypes, leaving high unmet need. It estimates about 20,000 new T-cell lymphoma patients worldwide each year. [ 4 ]
According to the company, GCC2005 is a fourth-generation allogeneic CAR-NK therapy targeting CD5, which is mainly expressed in T-cell lymphoma. It is designed to also express interleukin-15 (IL-15) to increase the persistence of the immune cells in the body, and GC Cell said it aims to develop it as a global first-in-class drug. [ 4 ]
GC Cell said it evaluated the safety and preliminary efficacy of GCC2005 in the Phase 1a dose-escalation stage, with results presented orally at last year's American Society of Hematology meeting and other international conferences. At the recent International Conference on Bone Marrow Transplantation (ICBMT 2026), it said, a long-term follow-up case was presented in which a patient reached complete remission after low-dose administration and maintained it for more than 18 months. [ 4 ]
“Having confirmed GCC2005's potential as a next-generation cell therapy in Phase 1a, we have completed dosing of the first patient in Phase 1b,” GC Cell CEO Won Seong-yong said, adding that the company will push Phase 1b quickly and prepare for a global registrational trial in T-cell lymphoma, where unmet medical need is high. [ 4 ]
Por qué importa
The trial is a mid-stage step for a Korean cell-and-gene therapy company aiming at a first-in-class CAR-NK product in a blood cancer with few treatment options. How Phase 1b goes will shape whether GC Cell proceeds to a global registrational study, which the company said is its next goal.
Datos clave
- GC Cell said GCC2005 (CD5 CAR-NK) has entered a Phase 1b trial and the first subject has been dosed. [ 1 , 2 , 3 , 4 ]
- The company said it completed the dose-escalation stage of the Phase 1a trial. [ 2 , 4 ]
- Phase 1b will optimise the dosing method and dose and add patients to the optimal dose cohort to strengthen safety and efficacy data. [ 2 , 4 ]
- The trial targets patients with NK/T-cell lymphoma that has relapsed after, or not responded to, standard treatment. [ 4 ]
- GC Cell plans to add major domestic trial sites, expanding to as many as six institutions. [ 4 ]
- GCC2005 targets CD5 and is designed to also express IL-15 to increase persistence of the immune cells in the body. [ 4 ]
- GC Cell said it aims to develop GCC2005 as a global first-in-class drug. [ 4 ]
Confirmado por varias fuentes
Aún sin aclarar
- The number of patients to be enrolled in Phase 1b and the length of the trial. The documents describe the trial design but give no enrolment target or schedule.
- When a global registrational trial would begin. GC Cell says it is preparing for and building a basis for one, but no timing is given.
- Whether the company will move the drug into second-line treatment, as it said it is considering. Document 4 describes this only as a plan under review, with no decision reported.
Qué dicen los medios locales
Cronología, hora local
- Korea Economic Daily reports GC Cell's GCC2005 has entered Phase 1b and the first subject has been dosed. [ 1 ]
- Chosun Ilbo reports GC Cell, a GC Green Cross subsidiary, has begun a Phase 1b trial of GCC2005 and recently completed the first patient dose. [ 2 ]
- Newsis reports GC Cell has entered Phase 1b of GCC2005 with the first dose completed. [ 3 ]
- Seoul Economic Daily publishes full details: Phase 1a dose escalation is complete, Phase 1b will optimise dose and enrol additional patients, and the company plans up to six domestic trial sites. [ 4 ]