drugset / Trial / NCT07617805

EGFR/HER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC

NCT07617805 ↗

Phase 1/2 Recruiting 42 enrolled Beijing Biotech
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This example Phase 1/2 protocol evaluates allogeneic EGFR/HER2 dual-target CAR-NK cells in adults with recurrent or metastatic HNSCC whose tumors meet protocol-defined co-expression criteria for EGFR and HER2/ERBB2. The study is designed as a biomarker-enriched, open-label, non-randomized trial with a dose-escalation safety lead-in followed by an expansion cohort at the recommended Phase 2 dose (RP2D).

Timeline

Start
2026-03-02
Primary completion
2027-03-14
Completion
2028-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject EGFR/HER2 Dual-Target CAR-NK Cells Cell therapy — —
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —