RecruitingPhase 1Phase 2NCT07641036

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

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

Sponsor

Beijing Biotech

Enrollment

30 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Intrahepatic Cholangiocarcinoma Extrahepatic Cholangiocarcinoma Gallbladder Carcinoma Biliary Tract Cancer Cholangiocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a biological treatment called EB-HC01 dual-target CARNK cells, and others for people with biliary tract cancer, cholangiocarcinoma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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