A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors

Key Inclusion Criteria:

Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, or uveal melanoma 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:

Ischemic heart disease (current or past), or clinically significant atrial or ventricular rhythm abnormality are excluded unless cardiac clearance is received.
Prior cell therapy or organ transplant
Have a primary or acquired immunodeficiency disorders
History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents
LVEF ≤ 45% or NYHA functional classification > 1
FEV1 ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value
Brain metastasis
Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
Additional exclusion criteria exist