Actively Recruiting
Dual-Target CAR-NK Cells Directed Against MSLN, EGFR, or HER2 in Advanced NSCLC
Led by Beijing Biotech · Updated on 2026-03-12
48
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a two-part, biomarker-guided Phase 1/2 study evaluating the safety, feasibility, and preliminary anti-tumor activity of off-the-shelf dual-target CAR-NK cells in participants with advanced or metastatic NSCLC whose tumors co-express at least two of the following antigens: Mesothelin (MSLN), EGFR, and HER2/ERBB2. Participants will receive lymphodepleting chemotherapy followed by infusion of the CAR-NK product matched to their tumor antigen profile. A data-driven interim assessment will be used to select the most suitable construct for expansion.
CONDITIONS
Official Title
Dual-Target CAR-NK Cells Directed Against MSLN, EGFR, or HER2 in Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed NSCLC that is unresectable Stage IIIB/IIIC or Stage IV with progression after standard therapy
- At least one measurable tumor lesion per RECIST v1.1
- Archival tumor tissue available or willingness to undergo fresh biopsy for antigen testing
- Tumor co-expresses at least two of these antigens: MSLN, EGFR, HER2/ERBB2
- ECOG performance status 0-1
- Adequate blood, liver, and kidney function as defined by study limits
- Life expectancy of at least 12 weeks
- Negative pregnancy test for those who can become pregnant
- Agreement to use effective contraception during study period
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Active, uncontrolled central nervous system metastases; stable treated CNS disease allowed if clinically stable and off high-dose steroids
- Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK, TCR-T) within 3 months or other therapies increasing severe toxicity risk
- History of severe cytokine release syndrome or neurotoxicity from prior therapies
- Significant interstitial lung disease or pneumonitis requiring steroids
- Uncontrolled lung conditions that would interfere with safety monitoring
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
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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