Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer
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
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-03-14
- Completion
- 2028-03-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EB-DT-CAR-NK | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | EB-DT-CAR-NK | Cell therapy | 4e+06 cells/kg | Intravenous |
| Subject | EB-DT-CAR-NK | Cell therapy | 8e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |