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OncoMatch/Clinical Trials/NCT04684459

Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors

Is NCT04684459 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Dual-targeting HER2 and PD-L1 CAR-T cells for peritoneal carcinoma metastatic.

Early Phase 1RecruitingSichuan UniversityNCT04684459Data as of May 2026

Treatment: Dual-targeting HER2 and PD-L1 CAR-T cellsCAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. In this study, the PD-L1 inhibitory signal was transformed into an activation signal in the tumor microenvironment, and enhanced the killing activity and survival ability of CAR-T cells. The HER-2/PD-L1 dual-targeting CAR-T will be investigated in patients with HER2-positive solid tumors, and all enrolled subjects will receive HER2/PD-L1 CAR T cells via intravenous or thoracic/peritoneal cavity infusion.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Biomarker criteria

Required: HER2 (ERBB2) overexpression (>20% of primary tumors or metastatic cells in the serous cavity by IHC or FISH)

Expressing HER2 >20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1×10^9/L, platelet count ≥ 75×10^9/L, absolute lymphocyte count ≥0.5×10^8/L, hemoglobin ≥ 8.0 g/dl

Kidney function

Creatinine clearance rate ≥60ml/min

Liver function

Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level

Cardiac function

Cardiac ejection fraction ≥50%, no pericardial effusion

Absolute neutrophil count ≥ 1×10^9/L, platelet count ≥ 75×10^9/L, absolute lymphocyte count ≥0.5×10^8/L, hemoglobin ≥ 8.0 g/dl; Creatinine clearance rate ≥60ml/min, Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level; Cardiac ejection fraction ≥50%, no pericardial effusion

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