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Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer
Sponsor: Beijing Biotech
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
Official title: A Phase 1/2, Open-label, Multicenter Study of Allogeneic Dual-target CLDN18.2/HER2 (ERBB2) CAR-NK Cells After Fludarabine/Cyclophosphamide Lymphodepletion in
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-03-02
Completion Date
2028-03-17
Last Updated
2026-04-24
Healthy Volunteers
No
Interventions
EB-DT-CAR-NK
Allogeneic, cord-blood-derived CAR-NK cells engineered to target CLDN18.2 and HER2 (ERBB2). Planned phase 1 dose levels: 2 x 10\^6, 4 x 10\^6, and 8 x 10\^6 cells/kg/infusion. Administered intravenously on Days 0, 3, and 7.
Fludarabine
Lymphodepleting chemotherapy administered intravenously at 30 mg/m\^2/day on Days -5 to -3.
Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously at 500 mg/m\^2/day on Days -5 to -3.
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China