Gender
All
Age Group
18 Years to 70 Years
Accepting Healthy Volunteers
No
Key Inclusion Criteria:
* Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, uveal melanoma, cutaneous melanoma, non-small cell lung cancer, or head and neck squamous cell carcinoma that has failed or is refractory to standard of care therapy
* Have at least one target lesion that can be used for response assessments and have at least 1 tumor amenable for tissue harvest for TIL manufacturing.
* ECOG performance status of 0 or 1
* Demonstrate adequate organ function
* Additional inclusion criteria exist
Key Exclusion Criteria:
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive
* Currently infected with HIV Type 1 and Type 2, hepatitis B virus (HBV), hepatitis C virus (HCV), treponema pallidum (e.g., syphilis), West Nile virus (WNV), Human T-lymphotropic virus types 1 or II (HTLV I/II), or cytomegalovirus (CMV)
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable
* Serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association [NYHA]), history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment. Patients who are > 60 years of age must undergo cardiology clearance exam and cardiac stress test.
* Prior cell therapy or organ transplant
* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents
* LVEF ≤ 45%
* FEV1 ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value
* Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
* Additional exclusion criteria exist