drugset / Trial / NCT07641023
Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC
Non-randomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-03-14
- Completion
- 2028-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EB-DuoNK-EGFR/HER2 | Cell therapy | — | Intravenous |
| Subject | EB-DuoNK-MSLN/EGFR | Cell therapy | — | Intravenous |
| Subject | EB-DuoNK-MSLN/HER2 | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |