Melanoma Clinical Trial
A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
This is a Phase 1 study to investigate TBio-4101. TBio-4101 is an autologous tumor infiltrating lymphocyte (TIL) therapy that utilizes tumor specific antigens to select, sort, and expand patient-specific tumor-reactive T-cells to be reinfused into the patient. The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion, followed by the TIL plus IL-2 infusion. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.
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
Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
Additional exclusion criteria exist
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There are 3 Locations for this study
Orlando Florida, 32806, United States More Info
Louisville Kentucky, 40202, United States More Info
Pittsburgh Pennsylvania, 15224, United States More Info
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