Engineered immune cells take aim at two cancer targets in hard-to-treat bile duct cancers
NCT ID NCT07641036
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new therapy called EB-HC01, which uses specially engineered natural killer (NK) immune cells to attack cancer cells that have two specific markers (HER2 and CEACAM5). The trial enrolls adults with advanced bile duct or gallbladder cancers that have worsened after standard chemotherapy. Participants receive the NK cells along with a short course of chemotherapy to prepare the immune system. The study first checks safety and dosing, then looks at whether the therapy shrinks tumors and how long any benefit lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EB-HC01 (dual-target HER2/CEACAM5 chimeric antigen receptor natural killer cells)
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced biliary tract cancers that have not responded to standard chemotherapy.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply broadly. The therapy involves lymphodepletion chemotherapy and carries risks of side effects, including immune reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bile may hold the key to guiding targeted treatment for bile duct and gallbladder cancers
- Second try: pumping chemo straight into the liver for tumors that outsmarted standard treatment
- Freezing tumors plus dual immunotherapy: a new attack on bile duct cancer
- Immunotherapy meets chemo: a new front against bile duct cancer
- Can Re-Assessing bile duct cancer treatment open the door to surgery?
- Radiation beads plus immunotherapy: a new way to attack liver cancer?