Actively Recruiting
Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer
Led by Beijing Biotech · Updated on 2026-03-10
48
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or post-resection cohorts if planned)
- Tumor antigen co-expression meeting central lab thresholds for one of these pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2
- ECOG performance status 0-1
- Adequate hematologic, renal, hepatic, and cardiac function as defined in protocol
- Recovery to Grade �3C=1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia)
- Life expectancy of at least 12 weeks
- Willingness to use effective contraception during study and for a protocol-defined period after cell infusion
You will not qualify if you...
- Active, uncontrolled infection including uncontrolled HBV/HCV or known uncontrolled HIV infection
- Active symptomatic CNS metastases or those requiring escalating steroids (stable treated CNS disease may be allowed)
- Prior gene-modified cellular therapy within 6 months or any prior therapy increasing risk of severe toxicity
- Clinically significant autoimmune disease needing systemic immunosuppression within past 6 months
- Concurrent anti-cancer therapy during the dose-limiting toxicity window (except protocol-permitted bridging)
- Pregnant or breastfeeding
- Significant cardiovascular disease, uncontrolled pulmonary disease, or other severe comorbidities increasing risk
- Known allergy to study chemotherapy components or required supportive medications
- Any condition interfering with participation, safety, or result interpretation per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here