RecruitingPhase 1Phase 2NCT07462650

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

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

Sponsor

Beijing Biotech

Enrollment

48 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic Adenocarcinoma of Colon

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called dual-target CAR-NK cell therapy for people with advanced colorectal cancer that has not responded to standard treatments. These engineered immune cells are designed to attack two specific proteins found on cancer cells at the same time, potentially making them more effective. **You may be eligible if...** - You have colorectal cancer that has spread or cannot be surgically removed - Your cancer progressed after at least standard chemotherapy treatments - Your tumor expresses certain proteins (CEA, GUCY2C, or HER2) confirmed by lab testing - You are reasonably functional (ECOG performance status 0–1) - Your organ function (kidneys, liver, blood) meets required levels - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your cancer has not been tested for the required protein markers - You have significant organ dysfunction - You have not recovered from side effects of prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEB-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