This 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,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.
Histologically confirmed breast carcinoma that is locally advanced, unresectable, or metastatic.
Disease subtype: HER2-positive breast cancer or triple-negative breast cancer (TNBC).
Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy.
At least one measurable lesion per RECIST v1.1.
Active, untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with treated CNS metastases may be eligible if clinically stable for ≥ 4 weeks and off high-dose steroids.
Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy.
Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).
Uncontrolled infection, including uncontrolled HBV, HCV, or HIV infection (controlled infections may be eligible per investigator).