drugset / Trial / NCT07467863

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

NCT07467863 ↗

Phase 1/2 Recruiting 48 enrolled Beijing Biotech
Non-randomizedParallel-groupOpen-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
2026-02-02
Primary completion
2027-02-14
Completion
2028-02-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Dual-target CAR-NK cells Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —