NCT07641036RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Jun 2026
- Start date
- 2 Mar 2026
- Primary completion date
- 14 Mar 2027
- Lead sponsor
- Beijing Biotech
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07641036
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 2 Mar 2026 to the primary completion date, 14 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior HER2-directed or CEA-directed gene-modified cell therapy.
- Ongoing systemic immunosuppression greater than 10 mg/day prednisone equivalent within 7 days before lymphodepletion.
- Prior allogeneic solid organ transplant or allogeneic stemcell transplant.
- Active autoimmune disease requiring systemic therapy within the previous 2 years.
Other illness
- Untreated or unstable CNS metastases or leptomeningeal disease.
- Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection.
- 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.
- Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.