T-Cell Therapy for Advanced Breast Cancer

Inclusion Criteria

• •Patients aged ≥18 years with metastatic breast cancer
• •Karnofsky performance status ≥70%
• •Patients with breast cancer that is pathologically confirmed at MSKCC (pathology from outside institutions is acceptable for the screening phase of the protocol) and defined by the following:
• •* HER2 negative (in cases of mixed HER2 results, the most recent pathology results considered reflective of the active cancer will be considered)
• •* Previously treated with at least 1 chemotherapy regimen for metastatic disease and documented progression
• •Expression of mesothelin must be confirmed by meeting 1 of the following criteria:
• •* Mesothelin expression (\>10% of the tumor expressing mesothelin) by IHC
• •* Elevated serum SMRP levels (\>1.0 nM/L)
• •Presence of measurable or evaluable disease
• •Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor), or radiotherapy must have been completed at least 14 days before administration of T-cells. Prior immunotherapy with checkpoint blockade (i.e., PD1 inhibitor, PDL1 inhibitor, or CTL4-antagonist or similar agent) must have been completed more than 1 month before the T-cell infusion.
• •\*Chemotherapy must have been completed at least 7 days prior to leukapheresis
• •Any major operation must have occurred at least 28 days before study enrollment.
• •All acute toxic effects of any previous radiotherapy, chemotherapy, or surgical procedures must have resolved to grade 1 or lower according to CTCAE
• •Lab requirements (hematology):
• •* White blood cell (WBC) count ≥3000 cells/mm\^3
• •* Absolute neutrophil count ≥1500 neutrophils/mm\^3
• •* Platelet count ≥100,000 platelets/mm\^3
• •Lab requirements (serum chemistry):
• •* Bilirubin \<1.5x upper limit of normal (ULN)
• •* Serum alanine aminotransferase/serum aspartate aminotransferase (ALT/AST) \<5x ULN
• •* Serum creatinine \<1.5x ULN or Cr \>1.5x ULN, but calculated clearances of \>60
• •Negative screen for human immunodeficiency virus (HIV), hepatitis B virus (HBV) antigen, and hepatitis C virus (HCV). If testing was performed during the previous 3 months, there is no need to repeat testing, as long as documentation of results is provided to the study site. Subjects must receive counseling and sign a separate informed consent form for HIV testing.
• •Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the period of drug administration and for 4 weeks after completion of the last administration of the study drug. An effective form of contraception is defined as oral contraceptives plus 1 form of barrier or double-barrier method contraception (condom with spermicide or condom with diaphragm).
• •Subjects must be able to understand the potential risks and benefits of the study and must be able to read and provide written, informed consent for the study.
• •Availability of archival tumor tissues (FFPE tissue block or 10-15 unstained slides)