drugset / Trial / NCT07589517
Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-02-02
- Primary completion
- 2027-03-14
- Completion
- 2028-03-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EB-DUO-CAR-NK-CEA/GCC | Unknown | — | Other |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |