Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
EB-DUO-CAR-NK-CEA/GCC: ogeneic 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
Lymphodepletion: Lymphodepleting chemotherapy ( fludarabine and cyclophosphamide) administered pre-infusion to facilitate CAR-NK cell engraftment.
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicities (DLTs) graded by CTCAE v5.0. — 28 Days
- Maximum tolerated dose (MTD) — 28 Days
- Objective response rate (ORR) by RECIST v1.1 in the expansion cohort. — 12 weeks
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | Recruiting |
More Beijing Biotech trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07589517 on ClinicalTrials.gov ↗ ← All trials in China