GC Cell Files Amendment for Phase 1 Clinical Trial of GCC2005 in Relapsed or Refractory NK/T-cell Malignancies
GC Cell submitted an amendment to the Phase 1 clinical trial plan for GCC2005 in relapsed or refractory NK and T-cell malignancies to the Ministry of Food and Drug Safety on June 11, 2026.
The amendment adds a single-dose cohort in the dose expansion phase to evaluate patient convenience and optimal dosing, and includes a backfill cohort to collect additional data to determine the recommended Phase 2 dose.
This disclosure does not involve any capital changes or financial restructuring, and while R&D expenses may increase with trial progress, the short-term financial impact is limited.
[AI Summary]GC Cell's Phase 1 clinical trial amendment for GCC2005 is a routine step to strengthen its R&D pipeline, with no dilution or governance changes, thus a neutral impact on shareholder value. However, clinical uncertainty and R&D cost burden remain as existing investment risks.
KOSDAQ Filing Information
Major Management Matters Related to Investment Decision (Application for Approval of Change in Clinical Trial Plan) (Application for Approval of Change in Domestic Phase 1 Clinical Trial Plan of GCC2005)