Curocell has received approval from the Ministry of Food and Drug Safety (MFDS) for a modification to the Phase 1/2 clinical trial plan for its CD19 CAR-T therapy 'CRC01' in patients with systemic lupus erythematosus (SLE).

According to Curocell on the 16th, the approval date for this modification is June 16, 2026. The company explained that the date of this event disclosure is based on the date they were notified of the clinical trial plan modification approval from the MFDS. The trial is an open-label, multicenter, single-arm Phase 1/2 study aimed at evaluating the tolerability, safety, and efficacy of CRC01 in patients with systemic lupus erythematosus, a severe refractory autoimmune disease. It is being conducted at domestic medical institutions, including Seoul St. Mary's Hospital. The primary reason for this modification approval is the 'revision of the primary evaluation endpoint.'

The clinical trial design and evaluation plan are as follows:

• Phase 1: The primary objectives are to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). • Phase 2: Evaluates the efficacy and safety of CRC01. • Evaluation Endpoint: 'Complete Renal Response (CRR)' at 24 weeks post-treatment is set as the primary evaluation endpoint. • Criteria for Complete Renal Response (CRR) (all three conditions must be met): - 24-hour urine protein of 0.5g or less, or UPCR of 0.5 or less - eGFR of 60mL/min/1.73㎡ or higher, or a decrease of no more than 20% from baseline - No use of lupus nephritis-related rescue medications within 8 weeks prior to evaluation

The statistical analysis is designed so that if the lower limit of the one-sided 97.5% confidence interval for the complete renal response rate at 24 weeks after CRC01 administration exceeds the response rate of existing treatments (30%), the efficacy is deemed statistically significant.

The trial period is approximately 48 months from the approval date, with a target of a minimum of 9 and a maximum of 18 subjects for Phase 1, and 30 patients who have completed CRC01 dosing for Phase 2. The expected completion date is July 31, 2029.

Meanwhile, the company urged investors to invest prudently and disclosed the following risks:

"The probability that a clinical trial drug will ultimately receive final approval as a pharmaceutical product is known to be approximately 10% statistically. During the clinical trial and product approval process, results may fall short of expectations, and as a result, there is always a possibility that our company may alter or abandon its commercialization plans. Investors are advised to invest prudently by comprehensively considering the investment risks disclosed through periodic disclosures and business reports."