Dual-Target CAR-NK Cells Directed Against MSLN, EGFR, or HER2 in Advanced NSCLC

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer, Advanced/Metastatic NSCLC

In brief

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.

Key facts

Study ID

NCT07467863

Run by

Beijing Biotech

People needed

48

Starts

2026-02-02

Expected to finish

2028-02-17

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed NSCLC that is unresectable Stage IIIB/IIIC or Stage IV, with radiographic progression on or after standard-of-care therapy (including platinum-based chemotherapy and immune checkpoint inhibitor when appropriate).
• At least one measurable lesion per RECIST v1.1.
• Archival tumor tissue available (or willingness to undergo a fresh biopsy) for antigen testing.
• Tumor co-expression of at least two of the following antigens at screening: MSLN, EGFR, HER2/ERBB2.
• Example thresholds: IHC ≥2+ in ≥50% of tumor cells for each required antigen (or an equivalent RNA expression threshold).
• ECOG performance status 0-1.
• Adequate organ function (hematologic, hepatic, renal) as defined by protocol laboratory limits.
• Life expectancy ≥12 weeks.
• Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception for the study-defined period.
• Ability to understand and willingness to sign written informed consent.

You may not qualify if…

• Active, uncontrolled central nervous system (CNS) metastases. Participants with previously treated/stable CNS disease may be eligible if clinically stable and off high-dose corticosteroids.
• Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK, TCR-T) within 3 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.
• History of severe cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior therapies.
• Clinically significant interstitial lung disease or pneumonitis requiring systemic steroids, or uncontrolled pulmonary comorbidity that would confound toxicity monitoring.

Where it is running

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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