OncoMatch/Clinical Trials/NCT07641023
Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC
Official title: A Phase 1/2, Open-label, Biomarker-guided Study of Dual-target Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Targeting Mesothelin (MSLN) With EGFR or HER2/ERBB2, or EGFR With HER2/ERBB2, in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC)
Is NCT07641023 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including Dual-target CAR-NK cells and Lymphodepleting chemotherapy for non-small cell lung cancer.
Treatment: Dual-target CAR-NK cells · Lymphodepleting chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MSLN overexpression (IHC ≥2+ in ≥50% of tumor cells (or equivalent RNA threshold))
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).
Required: EGFR overexpression (IHC ≥2+ in ≥50% of tumor cells (or equivalent RNA threshold))
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).
Required: HER2 (ERBB2) overexpression (IHC ≥2+ in ≥50% of tumor cells (or equivalent RNA threshold))
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).
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic therapy (platinum-based chemotherapy, immune checkpoint inhibitor) — standard-of-care for advanced/metastatic NSCLC
radiographic progression on or after standard-of-care therapy (including platinum-based chemotherapy and immune checkpoint inhibitor when appropriate)
Lab requirements
Blood counts
as defined by protocol laboratory limits
Kidney function
as defined by protocol laboratory limits
Liver function
as defined by protocol laboratory limits
Adequate organ function (hematologic, hepatic, renal) as defined by protocol laboratory limits.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07641023 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require MSLN?
Yes, MSLN overexpression is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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