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Clinical Trials in China / NCT07641036
Recruiting Phase 1/2

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

NCT07641036 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Biotech
Phase
Phase 1/2
Started
2026-03-02
Last updated
2026-06-11

Condition(s) studied

CholangiocarcinomaIntrahepatic CholangiocarcinomaExtrahepatic CholangiocarcinomaGallbladder CarcinomaBiliary Tract Cancer

Investigational drug(s) / intervention(s)

EB-HC01 dual-target CARNK cellsFludarabineCyclophosphamide

EB-HC01 dual-target CARNK cells: EB-HC01 dual-target CARNK cells

Fludarabine: Fludarabine

Cyclophosphamide: Cyclophosphamide

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically or cytologically confirmed unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma. * Disease progression after at least 1 prior gemcitabine/platinum-containing regimen in the advanced setting; prior durvalumab and prior HER2-targeted therapy are allowed. * Central biomarker confirmation of HER2 positivity (IHC 3+ or IHC 2+/ISH+ or ERBB2 amplification) and CEACAM5/CEA positivity (membranous expression in \>=20% of viable tumor cells by IHC). * At least 1 measurable lesion according to RECIST 1.1. * ECOG performance status 0-1. * Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol. * Resolved biliary obstruction or stable internal/external drainage for \>=7 days before lymphodepletion, with no active cholangitis. * Life expectancy \>=12 weeks. * Willingness to provide archival or fresh tumor tissue and serial blood samples for central biomarker testing and correlative studies. * Agreement to use protocol-specified contraception Exclusion Criteria: * Prior HER2-directed or CEA-directed gene-modified cell therapy. * Untreated or unstable CNS metastases or leptomeningeal disease. * Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection. * Ongoing systemic immunosuppression greater than 10 mg/day prednisone equivalent within 7 days before lymphodepletion. * Clinically significant interstitial lung disease, uncontrolled heart failure, unstable arrhythmia, or recent myocardial infarction. * Child-Pugh B or C liver disease, hepatic encephalopathy, or clinically significant refractory ascites. * Prior allogeneic solid organ transplant or allogeneic stemcell transplant. * Active autoimmune disease requiring systemic therapy within the previous 2 years. * Pregnancy or breastfeeding. * Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Shenzhen Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07641036 on ClinicalTrials.gov ↗ ← All trials in China