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OncoMatch/Clinical Trials/NCT07486089

Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)

Is NCT07486089 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Dual-target CAR-NK cells (EB-DT-CAR-NK) and Lymphodepleting chemotherapy for breast cancer (locally advanced or metastatic).

Phase 1/2RecruitingBeijing BiotechNCT07486089Data as of May 2026

Treatment: Dual-target CAR-NK cells (EB-DT-CAR-NK) · Lymphodepleting chemotherapyThis study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2/ERBB2, MUC1, ROR1, and in some TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Biomarker criteria

Required: HER2 (ERBB2) expression (expression of at least one candidate target antigen)

expression of at least one candidate target antigen (HER2/ERBB2, MUC1, or ROR1)

Required: MUC1 expression (expression of at least one candidate target antigen)

expression of at least one candidate target antigen (HER2/ERBB2, MUC1, or ROR1)

Required: ROR1 expression (expression of at least one candidate target antigen)

expression of at least one candidate target antigen (HER2/ERBB2, MUC1, or ROR1)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard therapies appropriate for the disease subtype and line of therapy

Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy

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

Exception: within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy

Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy

Lab requirements

Blood counts

anc ≥ 1.0 x 10^9/l; platelets ≥ 75 x 10^9/l; hemoglobin ≥ 8 g/dl

Kidney function

creatinine clearance ≥ 50 ml/min

Liver function

ast/alt ≤ 3x uln (≤ 5x with liver metastases); total bilirubin ≤ 1.5x uln

Cardiac function

left ventricular ejection fraction (lvef) ≥ 45% and no uncontrolled cardiac arrhythmia

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

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