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OncoMatch/Clinical Trials/NCT07467863

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

Is NCT07467863 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Dual-target CAR-NK cells and Lymphodepleting chemotherapy for non-small cell lung cancer.

Phase 1/2RecruitingBeijing BiotechNCT07467863Data as of May 2026

Treatment: Dual-target CAR-NK cells · Lymphodepleting chemotherapyThis 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.

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Extracted eligibility criteria

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)

Prior therapy

Must have received: platinum-based chemotherapy

radiographic progression on or after standard-of-care therapy (including platinum-based chemotherapy and immune checkpoint inhibitor when appropriate)

Must have received: immune checkpoint inhibitor — when appropriate

radiographic progression on or after standard-of-care therapy (including platinum-based chemotherapy and immune checkpoint inhibitor when appropriate)

Cannot have received: gene-modified cellular therapy (CAR-T, CAR-NK, TCR-T)

Exception: within 3 months

Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK, TCR-T) within 3 months

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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