Curocell Submits Amendment to Phase 1/2 Clinical Trial Plan for CRC01 in SLE, Modifying Primary Endpoint
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Submitted amendment to Phase 1/2 clinical trial plan for CD19 CAR-T therapy CRC01 in systemic lupus erythematosus, modifying primary endpoint to 24-week Complete Renal Response (CRR)
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Enrollment target: Phase 1 minimum 9 to maximum 18 subjects, Phase 2 30 subjects; trial duration approximately 48 months
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Statistical significance criterion: one-sided 97.5% confidence interval lower bound for CRR rate at 24 weeks exceeding 30%
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Amendment submission date: 2026-05-22, pending approval from MFDS
KOSDAQ Filing Information
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Filing: Major Management Matters Related to Investment Judgment (Application for Approval of Change of Clinical Trial Plan)
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Company: Curocell (372320)
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Submission: Curocell Inc.
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Receipt: 05-22-2026
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Under KRX KOSDAQ Market Division