NCT07641036 Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
| NCT ID | NCT07641036 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Biotech |
| Condition | Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-03-02 with a primary completion date of 2027-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07641036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07641036 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07641036 currently recruiting?
Yes, NCT07641036 is actively recruiting participants. Contact the research team at Seni-Lu@beijing-biotech.com for enrollment information.
Where is the NCT07641036 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07641036 clinical trial?
NCT07641036 is sponsored by Beijing Biotech. The trial plans to enroll 30 participants.