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RECRUITING
NCT07622940
PHASE1/PHASE2

Dual-Target CLDN18.2/HER2 CAR-NK Cells for Advanced Esophageal Adenocarcinoma

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

DRUG

Fludarabine

Lymphodepletion backbone

DRUG

Cyclophosphamide

Lymphodepletion backbone

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China