GC Cell announced in a regulatory filing on the 20th that it has received approval from the Ministry of Food and Drug Safety (MFDS) to amend its domestic Phase 1 clinical trial plan (IND) for 'GCC2005,' a treatment for relapsed or refractory NK/T-cell malignancies.

GCC2005 is a cell therapy designed to evaluate safety, tolerability, and preliminary efficacy in combination with lymphodepletion chemotherapy in the target patient population. The trial is being conducted at six domestic hospitals with a maximum of 53 subjects, with the goal of determining the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) through the Phase 1 trial.

■ Addition of Single-Dose Cohort is Key... Aimed at Determining Optimal Phase 2 Dose

The core of this amendment approval is the new addition of a single-dose treatment cohort in the dose-expansion phase (Phase 1b). Specifically, cohorts administering doses of 3.0×10⁷ cells/kg (once) and 1.0×10⁸ cells/kg (once) have been added. In addition, the company will be able to expand the operation of back-fill cohorts for dose groups where safety and tolerability have been confirmed.

The company explained that it added the single-dose cohort to improve treatment convenience for patients and determine the appropriate dosing method. The purpose is to secure additional data to finalize the optimal dosage and number of administrations for use in the upcoming Phase 2 clinical trial.

■ Approximately 36 Months Through August Next Year... Schedule Subject to Change

The estimated duration of the clinical trial is approximately 36 months from the date of approval, with an expected completion date of August 14, 2027. However, the schedule may change depending on factors such as subject recruitment status.

Meanwhile, the company informed investors through investment precautions that the statistical probability of a clinical trial drug ultimately receiving final drug approval is only around 10%. It added that if results fall short of expectations during the clinical trial or product approval process, there is a possibility that commercialization plans may be altered or suspended. The company urged investors to carefully consider the investment risks outlined in regulatory filings and business reports before making investment decisions.