OncoMatch/Clinical Trials/NCT07641036
Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
Is NCT07641036 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1/2 trial studies multiple treatments including EB-HC01 dual-target CARNK cells and Fludarabine for cholangiocarcinoma.
Treatment: EB-HC01 dual-target CARNK cells · Fludarabine · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: HER2 (ERBB2) ihc 3+ (IHC 3+)
HER2 positivity (IHC 3+ or IHC 2+/ISH+ or ERBB2 amplification)
Required: HER2 (ERBB2) ihc 2+/ish+ (IHC 2+/ISH+)
HER2 positivity (IHC 3+ or IHC 2+/ISH+ or ERBB2 amplification)
Required: HER2 (ERBB2) amplification
HER2 positivity (IHC 3+ or IHC 2+/ISH+ or ERBB2 amplification)
Required: CEACAM5 expression (membranous expression in >=20% of viable tumor cells by IHC)
CEACAM5/CEA positivity (membranous expression in >=20% of viable tumor cells by IHC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: gemcitabine/platinum-containing regimen — advanced setting
Cannot have received: her2-directed gene-modified cell therapy
Cannot have received: cea-directed gene-modified cell therapy
Lab requirements
Blood counts
Adequate marrow function as defined by the protocol
Kidney function
Adequate renal function as defined by the protocol
Liver function
Adequate hepatic function as defined by the protocol
Cardiac function
Adequate cardiac function as defined by the protocol
Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07641036 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior her2-directed gene-modified cell therapy, cea-directed gene-modified cell therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 ihc 3+ is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 ihc 2+/ish+ is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages