Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07641036
PHASE1/PHASE2

Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

EB-HC01 dual-target CARNK cells

EB-HC01 dual-target CARNK cells

DRUG

Fludarabine

Fludarabine

DRUG

Cyclophosphamide

Cyclophosphamide

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China