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Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC

Study acronym: DUO-NK-NSCLC
StatusRecruiting
PhasePhase 1/2
Started2026-03-02
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This is a two-part, biomarker-guided Phase 1/2 study evaluating the safety, feasibility, and preliminary anti-tumor activity of off-the-shelf dual-target CAR-NK cells in participants with advanced or metastatic NSCLC whose tumors co-express at least two of the following antigens: Mesothelin (MSLN), EGFR, and HER2/ERBB2. Participants will receive lymphodepleting chemotherapy followed by infusion of the CAR-NK product matched to their tumor antigen profile. A data-driven interim assessment will be used to select the most suitable construct for expansion.
Trial Details
NCT Number NCT07641023
Lead Sponsor Beijing Biotech
Conditions Non-Small Cell Lung Cancer, Advanced/Metastatic
Enrollment 60 participants
Start Date 2026-03-02
Primary Completion 2027-03-14 (estimated)
Study Completion 2028-06-17 (estimated)
Updated on ClinicalTrials.gov 2026-06-11