Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer (NCT07641036) | Clinical Trial Compass
RecruitingPhase 1/2
Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
China30 participantsStarted 2026-03-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is still in Phase 1/2 and is primarily measuring dose-limiting toxicities and adverse events, what does that mean for what's actually known so far about whether this CAR-NK cell therapy is safe or effective for biliary tract cancer?
2This trial targets both HER2 and CEA proteins on cancer cells — before considering whether this might be worth discussing with you, how would we find out if my tumor actually expresses those markers, and does my specific diagnosis of cholangiocarcinoma or gallbladder carcinoma make a difference?
3Compared to standard treatments currently available for advanced biliary tract cancer, what would I potentially be giving up or delaying if we explored this experimental CAR-NK cell approach instead?
4CAR-NK cell therapy is a fairly new type of cell-based treatment — can you explain how it works differently from chemotherapy or immunotherapy I may have heard about, and what kinds of side effects or monitoring would be involved based on what's known so far?
5Given that this trial is still actively recruiting and is in an early phase focused on safety, is this something you think is worth exploring for my specific situation right now, or would you recommend exhausting other options first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.