Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
2. Locally advanced and unresectable, or metastatic NSCLC.
3. Histologically or cytologically confirmed, either squamous or non-squamous NSCLC.
4. Measurable disease as per RECIST 1.1
5. Willingness to undergo bone marrow aspiration (BMA).
6. No more than one treatment regimen following an anti-PD-1 antibody containingtreatment regimen prior to BMA collection. a. Subjects may have BMA collected while on an anti-PD-1 antibody containing treatmentregimen or while on a treatment regimen immediately following an anti-PD-1 antibodycontaining treatment regimen.
7. BMA may be collected while on an anti-PD-1 antibody containing treatment regimen orwhile on a treatment regimen immediately following an anti-PD-1 antibody containingtreatment regimen. However, the subjects must have radiographic evidence of diseaseprogression prior to lymphodepletion.
8. ≥ 21 days have lapsed since last cytotoxic chemotherapy treatment prior to collectionof the BMA.
9. Previous treatment with the appropriate targeted therapy if the subject has knownEGFR/ALK/ROS1 rearrangements.
10. Willingness to provide a fresh tumor biopsy during Screening Period or formalin-fixed,paraffin-embedded tissue collected at the time of most recent relapse. Note: Archivaltissue regardless of biopsy date may be considered.
11. Adequate renal, hepatic and bone marrow function defined as total bilirubin </= 1.5 xULN (except for subjects with Gilbert's disease ≤ 3.0 x ULN with direct bilirubin </= 1.5 x ULN ). Aminotransferase (AST) / Alanine Aminotransferase (ALT) </= 3.0 X ULN (subjects with liver involvement will be allowed </= 5.0 X ULN). Serum creatinine </= 1.5 x ULN; if serum creatinine is 1.5 to 2.0 × ULN, then the creatinine clearance (calculated using the Cockcroft-Gault formula or measured) must be ≥ 40 mL/min.Lymphocyte >/= 0.7 x 10^9/L. ANC >/= 1.5 x 10^9/L. Platelets >/= 100 × 10^9/L. WBC >/= 2.0 ×10^9/L. Hemoglobin > 9.0 g/dL.
12. Women of childbearing potential and male subjects (even if they are surgicallysterilized or had a vasectomy) and their partners must agree to abstain or to use aneffective form of birth control during the study for at least 6 months followingadministration of the last dose of lymphodepletion or for at least 5 months followingthe last dose of nivolumab for females and 7 months for males, whichever is longer. Inaddition, male subjects must not donate sperm during this period.
13. Capable of giving and has provided a signed ICF, which includes compliance with therequirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

1. Insufficient activation/expansion of T cells or other problems with the subject'sMILs™ - NSCLC product which would prohibit administration.
2. Major surgical procedure within 7 days of the first dose of lymphodepletion treatment.
3. Prior malignancy active within the previous 3 years from date of BMA collection exceptfor locally curable cancers that have been apparently cured, such as basal or squamouscell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate,cervix, or breast.
4. Subjects with symptomatic uncontrolled brain metastases requiring treatment withsteroids or anti-seizure medications within 28 days prior to the BMA are excluded.However, participants with brain metastases that have been previously treated and arestable on subsequent scan(s) are allowed and subjects with untreated possible brainmetastases that are new at the time of screening and are < 1 cm and asymptomatic areallowed. Subjects with asymptomatic untreated CNS disease may undergo BMA prior totreatment of such disease.
5. Infection requiring treatment with intravenous antibiotics, antifungal, or antiviralagents within 7 days prior to the BMA.
6. Presence of an autoimmune disease requiring active systemic treatment.
7. Clinically significant, uncontrolled cardiovascular disease, including congestiveheart failure Grade III or IV according to the New York Heart Associationclassification, myocardial infarction or unstable angina within the previous 6 monthsprior to BMA collection.
8. Known diagnosis of human immunodeficiency virus (HIV) or active viral hepatitis.
9. Administration of neutrophil growth factor support within 14 days prior to the BMA.
10. Use of systemic corticosteroids (glucocorticoids) for greater than one day within 28days prior to the BMA.
11. Planned use of systemic corticosteroids (glucocorticoids) for greater than one daywithin 28 days prior to MILs™ - NSCLC administration.
12. Prior radiation to both sides of the pelvis. Prior radiation to one side of the pelvisis permitted as long as the other side of the pelvis.
13. Subjects with history of life-threatening toxicity related to prior immune therapyexcept those that are unlikely to re-occur with standard countermeasures.
14. Receipt of live attenuated vaccine within 30 days of planned Day 0.
15. History of allergy or hypersensitivity to MILs™-NSCLC, cyclophosphamide, fludarabine,nivolumab, tadalafil or their components.
16. Pregnant or lactating females.
17. Prior or ongoing clinically significant illness, medical condition, surgical history,physical finding, or laboratory abnormality that, in the Investigator's opinion, couldaffect the safety of the subject or impair the assessment of study results.
18. Unwilling or unable to comply with the protocol.