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

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.

Trial Details

NCT ID
NCT07462650
Phase
PHASE1 / PHASE2
Sponsor
Beijing Biotech
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • EB-DUO-CAR-NK-CEA/GCC (IV)
Locations (sample)
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

  • Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible …
  • Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned).
  • Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2.
  • ECOG performance status 0-1.

For full eligibility, visit ClinicalTrials.gov.

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