GC Cell advances GCC2005 CAR-NK therapy through AI optimization and compassionate use approval

GC Cell is advancing its core pipeline, GCC2005, a CD5-targeted allogeneic CAR-NK cell therapy designed to treat refractory T-cell lymphoma. The company has entered into a joint research agreement with QuantHealth, a global leader in AI-based clinical trial simulation, to optimize the design of upcoming Phase 2 multi-national clinical trials. QuantHealth will utilize AI platforms and real-world data to predict treatment responses and compare efficacy against competing therapies, helping to reduce uncertainty in the global development process.

Additionally, the South Korean Ministry of Food and Drug Safety has granted compassionate use approval for GCC2005. This allows Seoul National University Hospital to administer the investigational drug to patients with peripheral T-cell lymphoma who have exhausted existing treatment options. GCC2005 is a fourth-generation therapy engineered to co-express Interleukin-15 (IL-15) to enhance immune cell persistence. Having completed Phase 1a dosing, GC Cell is currently preparing to initiate Phase 1b clinical trials.