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Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
Sponsor: Beijing Biotech
Summary
This example phase 1/2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.
Official title: A Phase 1/2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2/CEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-03-02
Completion Date
2028-10-17
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
EB-HC01 dual-target CARNK cells
EB-HC01 dual-target CARNK cells
Fludarabine
Fludarabine
Cyclophosphamide
Cyclophosphamide
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China