Aiming to Optimize the Clinical Trial Design for GCC2005

GC Cell announced on September 16 that it has signed a joint research agreement with QuantHealth, a global artificial intelligence (AI)-based clinical trial simulation company, to optimize the clinical trial design for its new drug candidate 'GCC2005 (CD5 CAR-NK)'.


GC Cell Signs Joint Research Agreement with AI Clinical Trial Simulation Company 'QuantHealth' View original image

This collaboration was established to further refine the global clinical development strategy for GCC2005 and to enhance the design quality of the planned Phase 2 multinational clinical trial (MRCT).


QuantHealth plans to utilize its AI-powered clinical trial simulation platform and predictive engine, as well as real-world clinical data (RWD), to forecast treatment responses and efficacy endpoints for different patient cohorts, conduct comparative analyses against competing therapies, and review various clinical trial scenarios.


Based on these analytical findings, GC Cell will refine key clinical design elements, such as patient selection criteria and evaluation variables, in order to optimize the Phase 2 clinical trial design for GCC2005 and minimize uncertainties in the global clinical development process.


GCC2005 is an allogeneic CAR-NK cell therapy targeting CD5. It is a core pipeline of GC Cell being developed as a first-in-class global innovative drug for the treatment of refractory T-cell lymphoma.


GC Cell has completed subject enrollment for the Phase 1a trial of GCC2005 targeting patients with refractory T-cell lymphoma. The company is currently preparing to initiate a Phase 1b trial at major domestic research institutions. Based on the results of the Phase 1b trial and subsequent developments, GC Cell plans to pursue a Phase 2 multinational registration trial as part of its global expansion strategy.



QuantHealth intends to use its AI models, which are trained on extensive biomedical knowledge graphs and real-world data, to predict therapeutic outcomes between drugs and patients and assess a variety of clinical trial and drug development scenarios.


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