Dual-target CAR-NK therapy for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2 interventional study evaluating the safety, tolerability, and early anti-tumor activity of allogeneic dual-target CAR-NK cells in adults with advanced or metastatic colorectal cancer. Participants are assigned to one of three target-pair arms based on tumor antigen co-expression: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2, with a dose-escalation phase followed by expansion of a preferred target pair. The study uses central lab IHC to confirm biomarker co-expression and a prespecified algorithm to select the optimal target pair for expansion, considering safety, manufacturing feasibility, and early efficacy signals. CAR-NK therapy is explored as a potentially safer, off-the-shelf option for solid tumors with limited antigen expression specificity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies.
* 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.
* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol.
* Recovered to Grade ≤1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia).
* Life expectancy ≥ 12 weeks.
* Willingness to use effective contraception during study and for a protocol-defined period after cell infusion.

Exclusion Criteria:

* Active, uncontrolled infection (including uncontrolled HBV/HCV) or known uncontrolled HIV infection.
* Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.)
* Prior gene-modified cellular therapy (CAR-T/CAR-NK/TCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.
* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.
* Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window.
* Pregnant or breastfeeding.
* Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk.
* Known hypersensitivity to study chemotherapy components (fludarabine/cyclophosphamide) or required supportive medications.
* Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.