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RECRUITING
NCT07462650
PHASE1/PHASE2

Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

Summary

This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy/biomarker signals) will be selected for dose expansion.

Official title: A Phase 1/2, Biomarker-Assigned, Open-Label Dose Escalation and Expansion Study of Allogeneic Dual-Target CAR-NK Cells Targeting CEA (CEACAM5) and/or GUCY2C (GCC) With an Exploratory HER2/ERBB2-Positive Cohort in Subjects With Advanced or Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-02-01

Completion Date

2028-12-22

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

EB-DUO-CAR-NK-CEA/GCC (IV)

Allogeneic dual-target CAR-NK cells manufactured from cord blood-derived NK cells, genetically engineered to express a tandem (dual-binding) CAR, an IL-15 support element (e.g., membrane-bound IL-15 or IL-15/IL-15R fusion), and an inducible suicide switch

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China