Clinical Trial

Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer

Study acronym: DUET-GEJ
Recruiting Phase 1/2
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Summary
This example planning study proposes a phase 1/2 evaluation of an allogeneic, cord-blood-derived dual-target CAR-NK product directed against CLDN18.2 and HER2 (ERBB2) in adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma after prior standard systemic therapy. CLDN18.2 is selected as the anchor antigen because it has the more disease-specific gastric/GEJ cell-therapy development footprint, while HER2 is retained as the complementary second antigen to address co-expressing or heterogeneous disease. Phase 1 uses a 3+3 dose-escalation design after fludarabine/cyclophosphamide lymphodepletion followed by three intravenous CAR-NK infusions on Days 0, 3, and 7. Phase 2 expansion evaluates the recommended phase 2 dose and preliminary antitumor activity
Trial Details
NCT Number NCT07551362
Lead Sponsor Beijing Biotech
Conditions Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
Enrollment 36 participants
Start Date 2026-03-02
Primary Completion 2027-03-14 (estimated)
Study Completion 2028-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-24