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EGFR/HER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC
Sponsor: Beijing Biotech
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).
Official title: A Phase 1/2, Open-Label, Biomarker-Enriched Study of Allogeneic EGFR/HER2 Dual-Target CAR-NK Cells Following Fludarabine/Cyclophosphamide Lymphodepletion in Adults With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-03-02
Completion Date
2028-05-17
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
EGFR/HER2 Dual-Target CAR-NK Cells
Allogeneic donor-derived activated /expanded NK cells engineered to express a dual EGFR/HER2 chimeric antigen receptor, membrane-bound IL-15, and an inducible caspase-9 safety switch
Fludarabine
Lymphodepleting chemotherapy administered before the first infusion according to protocol-defined dose and schedule.
Cyclophosphamide
Lymphodepleting chemotherapy administered before the first infusion according to protocol-defined dose and schedule.
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China