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RECRUITING
NCT07617805
PHASE1/PHASE2

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

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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

DRUG

Fludarabine

Lymphodepleting chemotherapy administered before the first infusion according to protocol-defined dose and schedule.

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy administered before the first infusion according to protocol-defined dose and schedule.

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China