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

Sponsor
Beijing Biotech
Study ID
NCT07641036
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer
  • Cholangiocarcinoma
  • Extrahepatic Cholangiocarcinoma
  • Gallbladder Carcinoma
  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EB-HC01 dual-target CARNK cells — BIOLOGICAL
    EB-HC01 dual-target CARNK cells
  • Fludarabine — DRUG
    Fludarabine
  • Cyclophosphamide — DRUG
    Cyclophosphamide

Study Details

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.

Key Dates

First listed
Jun 11, 2026
Start date
Mar 2, 2026
Status verified
Jun 2026
Primary completion
Mar 14, 2027
Completion
Oct 17, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EB-HC01 after lymphodepletion
    Participants with biomarker-confirmed HER2/CEACAM5-positive advanced biliary tract cancer receive fludarabine plus cyclophosphamide on Days -5 to -3, followed by EB-HC01 intravenously on Days 0 and 7 of each 28-day cycle. Up to 2 cycles are permitted during doseescalation and up to 4 cycles are allowed in expansion in the absence of progression or prohibitive toxicity.

Primary Outcome Measure

Dose-Limiting Toxicities [ Time Frame: 28 Days ]

Central Contacts

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