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Dual-Target CLDN18.2/HER2 CAR-NK Cells for Advanced Esophageal Adenocarcinoma
Sponsor: Beijing Biotech
Summary
This example study evaluates the safety, feasibility, cellular kinetics, and preliminary anti-tumor activity of EBNK-1822H2, an illustrative allogeneic cord blood-derived dual-target CAR-NK cell product directed against CLDN18.2 and HER2, in adults with relapsed/refractory or metastatic esophageal adenocarcinoma after standard therapy. The study uses dose escalation followed by biomarker-defined expansion and prospectively records EGFR expression as an exploratory biomarker of antigen escape.
Official title: A Phase 1/2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target CLDN18.2/HER2 Chimeric Antigen Receptor Natural Killer Cells (EBNK-1822H2) in Adults With Relapsed, Refractory, or Metastatic Esophageal Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-03-02
Completion Date
2028-03-17
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells
Illustrative allogeneic cord blood-derived NK-cell product engineered to recognize CLDN18.2 and HER2.
Fludarabine
Lymphodepletion backbone
Cyclophosphamide
Lymphodepletion backbone
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China