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