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Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer

Study acronym: DUO-CRC-NK-111
StatusRecruiting
PhasePhase 1/2
Started2026-02-02
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This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy/biomarker signals) will be selected for dose expansion.
Trial Details
NCT Number NCT07589517
Lead Sponsor Beijing Biotech
Conditions Colorectal Cancer, Metastatic Colorectal Adenocarcinoma, Unresectable Colorectal Cancer
Enrollment 48 participants
Start Date 2026-02-02
Primary Completion 2027-03-14 (estimated)
Study Completion 2028-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-05-15