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4 clusters · 6 sources · 51 days · First seen · Last updated

GC Cell advances GCC2005 CAR-NK therapy development

Overview

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 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).

Following the completion of the Phase 1a dose-escalation phase, GC Cell 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.

Entities

GC Cell · GCC2005 · Seoul National University Hospital · ICBMT 2026 · Gilead Sciences

Timeline

  1. [HEALTH] 2 sources
    GC Cell begins Phase 1b clinical trials for GCC2005

    GC Cell has entered Phase 1b clinical trials for GCC2005, a CAR-NK cell therapy targeting T-cell lymphoma, to optimize dosage and prepare for global registration trials.

  2. [HEALTH] 4 sources
    GC Cell presents GCC2005 clinical trial results at ICBMT 2026

    GC Cell reported a 62.5% objective response rate in Phase 1a clinical trials for its GCC2005 CAR-NK cell therapy targeting relapsed or refractory NK/T-cell lymphoma.

  3. [HEALTH] 4 sources
    GC Cell advances GCC2005 CAR-NK therapy through AI optimization and compassionate use approval

    GC Cell is optimizing its GCC2005 CAR-NK lymphoma therapy via AI simulations with QuantHealth and has received compassionate use approval for patients at Seoul National University Hospital.

  4. [HEALTH] 2 sources
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Sources

biotimes.co.kr · biz.heraldcorp.com · bosa.co.kr · hin.company · m.sportalkorea.com · thebionews.net

This summary has been updated 2 times: see revision history