CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer

Inclusion Criteria:

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines
Agreement to research biopsies on study, once during study and end of study, exceptions may be granted with study principal investigator (PI) approval
>= 18 years
Eastern Cooperative Oncology Group (ECOG) =< 2
Histologically confirmed metastatic triple negative breast cancer. Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) =< 10% by immunohistochemistry (IHC) and HER2 negative, per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
Measurable disease by RECIST 1.1
Patients must have progressed on or been intolerant of at least 2 prior lines of therapy for advanced/metastatic disease. Patients that qualify for immunotherapy and/or PARP inhibitors must have progressed on or been intolerant of these agents
Fully recovered from the acute toxic effects (except alopecia) to =< grade 2 to prior anti-cancer therapy
Must have a superficial tumor (cutaneous, subcutaneous), breast lesion or nodal metastases amenable to safe repeated intratumoral injections per treating physician and interventional radiologist review

Absolute neutrophil count (ANC) >= 1,500/mm^3

NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement

Platelets >= 100,000/mm^3

NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
Total bilirubin =< 1.5 X upper limit of normal (ULN)

Aspartate aminotransferase (AST) =< 2.5 x ULN

If liver metastases are present: AST =< 5 x ULN

Alanine aminotransferase (ALT) =< 2.5 x ULN

If liver metastases are present: ALT =< 5 x ULN
Serum creatinine =< 1.5 mg/dL or creatinine clearance of >= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Prothrombin (PT) =< 1.5 x ULN
Activated partial thromboplastin time (aPTT) =< 1.5 x ULN
Women of childbearing potential (WOCBP): negative serum pregnancy test

Agreement by females and males of childbearing potential* and their partners to use an effective method of birth control (defined as a hormonal or barrier method) or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Exclusion Criteria:

Chemotherapy, biological therapy, immunotherapy or investigational therapy within 14 days prior to day 1 of protocol therapy
Major surgery or radiation therapy within 28 days of study therapy
Has received a vaccination within 30 days of first study injection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Clinically significant uncontrolled illness
Active infection requiring antibiotics
Known history of immunodeficiency virus (HIV)
Patients with a known history of hepatitis B or hepatitis C infection who have active disease as evidenced by hepatitis (Hep) B surface antigen status or Hep C polymerase chain reaction (PCR) status obtained within 14 days of cycle 1, day 1
Another malignancy within 3 years, except non-melanomatous skin cancer
Females only: Pregnant or breastfeeding
Patients may not have clinically unstable brain metastases. Patients may be enrolled with a history of treated brain metastases that are clinically stable for >= 4 weeks prior to start of study treatment
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)