drugset / Trial / NCT07641023

Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC

NCT07641023 ↗

Phase 1/2 Recruiting 60 enrolled Beijing Biotech
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

EvaluationDrugModalityDoseRoute
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 — —