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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2, open-label, biomarker-selected trial of EB-HC01, an off-the-shelf dual-target CAR-NK product. The study uses a 3+3 dose-escalation part to find a safe RP2D after a reduced-intensity lymphodepletion, followed by an expansion to assess preliminary anti-tumor activity and biomarker correlations at RP2D. Participants have biliary tract cancers with confirmed HER2 and CEACAM5 positivity and progression after gemcitabine/platinum therapy. Correlative studies track CAR-NK persistence, cytokine kinetics, and biomarker changes in ctDNA, CA19-9, CEA, and tumor tissue. EpCAM is not used for enrollment to maintain safety in this first systemic BTC study. If safe, the trial will evaluate preliminary efficacy and biomarker associations in an expanded cohort.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.