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GC Cell advances GCC2005 CAR-NK therapy development

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2026-09-21 02:42 UTC → 2026-10-07 02:16 UTC · added removed

GC Cell is advancing its GCC2005 CAR-NK cell therapy, a CD5-targeted allogeneic treatment for refractory T-cell lymphoma. The company has partnered with QuantHealth to use AI-based clinical trial simulations to optimize the design of upcoming Phase 2 multi-national trials and predict treatment responses. Furthermore, the South Korean Ministry of Food and Drug Safety has granted compassionate use approval for GCC2005. This allows Seoul National University Hospital to provide the investigational drug to patients with peripheral T-cell lymphoma who have no remaining treatment options. GCC2005 is a fourth-generation therapy engineered to co-express Interleukin-15 (IL-15) to enhance immune cell persistence. At the ICBMT 2026 conference, conference in Busan, GC Cell presented interim Phase 1a clinical trial results. Based on data through October 31, 2025, eight evaluable patients showed an objective response rate (ORR) of 62.5%, including three complete remissions (CR) and two partial remissions (PR). Notably, one patient with angioimmunoblastic T-cell lymphoma (AITL) has maintained complete remission for 18 months following low-dose administration. Initial safety assessments reported no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD). Having completed Following the completion of the Phase 1a dosing, dose-escalation phase, GC Cell is now preparing for has commenced Phase 1b clinical trials, having successfully administered the first patient in this stage. The Phase 1b trial aims to optimize dosage and administration methods for patients with relapsed or unresponsive NK and T-cell lymphomas. Data from this phase will be used to establish the Recommended Phase 2 Dose (RP2D) to support future global registration trials. To accelerate development, GC Cell plans to expand its clinical trial sites in South Korea to a maximum of six institutions.

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  1. 2026-10-07 02:16 UTC GC Cell advances GCC2005 CAR-NK therapy development
  2. 2026-09-21 02:42 UTC GC Cell advances GCC2005 CAR-NK therapy development
  3. 2026-09-18 00:52 UTC GC Cell CAR-NK therapy development

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