[Seoul=NewsDesk] GC Cell announced on the 11th that it has filed an application for an Investigational New Drug (IND) amendment for its cell therapy candidate 'GCC2005' with the Ministry of Food and Drug Safety (MFDS). Both the date of the amendment application and the date of occurrence are June 11, 2026.

This amendment application involves a partial adjustment to the trial design of the ongoing Phase 1 clinical trial for GCC2005, which targets patients with relapsed or refractory NK and T-cell malignancies. The trial is scheduled to be conducted at six domestic hospitals. (However, participating institutions may change depending on the progress of the clinical trial.) The official title of this clinical trial is 'Phase 1, multicenter clinical trial to evaluate the safety, tolerability, and preliminary efficacy of GCC2005 in combination with lymphodepleting chemotherapy in the treatment of patients with relapsed or refractory NK and T-cell malignancies.'

■ Addition of Single-Dose Cohort and Backfill Cohort Through this amendment application, GC Cell added a single-dose cohort in the dose-expansion phase (Phase 1b). This aims to ensure patient convenience in treatment and to determine the appropriate dosing method. Additionally, the company plans to secure supplementary data through a backfill cohort to determine the optimal dosage and frequency of administration for future Phase 2 clinical trials.

■ Targeting Up to 53 Subjects... Safety and Tolerability Evaluation as Primary Goal The clinical trial will be conducted on up to 53 patients. The number of subjects may vary depending on safety evaluation results, with 18 patients expected to participate in the dose-escalation phase (Phase 1a) and up to 35 patients in the dose-expansion phase (Phase 1b).

Up to four dose cohorts will be evaluated during the dose-escalation phase. The specific composition is as follows: ▲ 1.0×10⁶ cells/kg (3 administrations) ▲ 3.0×10⁶ cells/kg (3 administrations) ▲ 1.0×10⁷ cells/kg (3 administrations) ▲ 3.0×10⁷ cells/kg (3 administrations)

The single-dose cohort added to the dose-expansion phase through this amendment application is as follows: ▲ 3.0×10⁷ cells/kg (1 administration) ▲ 1.0×10⁸ cells/kg (1 administration)

The company plans to evaluate the safety and tolerability of GCC2005 as the primary goal of this clinical trial, determining the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). The clinical trial period is expected to be approximately 36 months from the date of approval, though it may vary depending on the speed of patient recruitment.

■ "Statistical Probability of Approval is Around 10%... Urge Cautious Investment" GC Cell stated, "We plan to immediately submit a related disclosure upon the approval of the clinical trial plan in the future," adding, "The contents of this disclosure will be utilized as future press releases and IR materials."

The company further explained, "The probability of the clinical trial drug finally being approved as a pharmaceutical product is statistically known to be around 10%." It added, "Results that do not meet expectations may occur during the clinical trial and product approval process, and thus there is always a possibility that our company may change or abandon its commercialization plan." In conclusion, the company urged, "Investors are advised to invest carefully by comprehensively considering the disclosed investment risks through current disclosures and business reports."