OncoMatch/Clinical Trials/NCT04684459
Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors
Is NCT04684459 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies Dual-targeting HER2 and PD-L1 CAR-T cells for peritoneal carcinoma metastatic.
Treatment: Dual-targeting HER2 and PD-L1 CAR-T cells — CAR-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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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)
Demographics
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04684459 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
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.
Check if I qualifyRelated pages