Genetically Engineered Cells (huCART-meso Cells) for the Treatment of Mesothelin Expressing Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Inclusion Criteria

• Patients with locally advanced unresectable or metastatic triple-negative breast cancer (TNBC), as confirmed by all of the following: * Estrogen receptor (ER)-negative or low-ER positive (=< 10% by immunohistochemistry [IHC]) * Progesterone receptor (PR)-negative or low-PR positive (=< 10% by IHC) * HER2 negative by IHC/fluorescence in situ hybridization (FISH)
• Patients with an accessible lesion that can be targeted for both intratumoral injection and surgical excision/biopsy by either a surgeon or interventional radiology
• Confirmed tumor mesothelin expression by >= 10% of malignant cells by IHC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Bilirubin =< 2.0 x upper limit of normal (ULN)
• Serum creatinine =< 1.5 x ULN
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/ =< 3 x ULN
• Must have a minimum level of pulmonary reserve defined as =< grade 1 dyspnea and pulse oxygen > 92% on room air
• Left ventricle ejection fraction (LVEF) >= 45% confirmed by echocardiogram
• Male and female patients >= 18 years of age
• Provides written informed consent
• Subjects of reproductive potential must agree to use acceptable birth control methods

Exclusion Criteria

• Active invasive cancer other than the study-targeted malignancy
• Evidence of active hepatitis B or hepatitis C. The following would not qualify as an active infection, thus would not exclude the subject from participating: * Positive hepatitis B virus (HBV) serology with undetectable viral load and ongoing antiviral prophylaxis for potential HBV reactivation * Positive hepatitis C virus (HCV) serology with quantitative polymerase chain reaction (PCR) for plasma HCV ribonucleic acid (RNA) below the lower limit of detection, with or without concurrent antiviral HCV treatment
• Patients with ongoing or active infection
• Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to >= 10 mg/day of prednisone. Patients with autoimmune neurologic diseases (such as multiple sclerosis [MS]) will be excluded
• Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (=< 10mg daily equivalent of prednisone). Use of inhaled or topical steroids is allowable
• History of allergy or hypersensitivity to study product excipients (human serum albumin, dimethyl sulfoxide [DMSO], and Dextran 40)
• Pregnant or breastfeeding women
• Any clinically significant pericardial effusion, class II-IV cardiovascular disability according to the New York Heart Association Classification or other cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study. This determination will be made by a cardiologist if cardiac issues are suspected
• Patients with significant lung disease as follows: * Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden * Patients with radiographic and/or clinical evidence of active radiation pneumonitis * Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc)
• Patients with active central nervous system (CNS) involvement. Screening for this (e.g. lumbar puncture, brain magnetic resonance imaging [MRI], etc) is not required unless the patient is symptomatic and/or radiographic findings are present