Beth Israel Deaconess Medical Center
This study aims to evaluate autologous ex vivo expanded tumor-infiltrating lymphocyte therapy (lifileucel/LN-145) for kidney cancer after failure of PD-1 blockade.
This is a Phase II single-arm trial of tumor-infiltrating lymphocyte (TIL) therapy in kidney cancer. Briefly, participants who meet eligibility criteria undergo surgical removal of a metastasis or primary tumor to provide material for generation of the TIL product in a lab, which involves growing and expanding the immune cells contained in the tumor before infusing the TIL product into the patient. Baseline evaluations occur before tumor harvest, and participants who proceed on study undergo tumor resection so tissue can be shipped to a manufacturing facility to create the autologous TIL prod…
Inclusion Criteria: * Histologically or cytologically confirmed, advanced or metastatic renal cell carcinoma with clear cell, papillary, sarcomatoid (with or without other subtypes present), or unclassified histology. Other non-clear cell subtypes are also eligible if the patient has had a prior documented response to immune checkpoint inhibitor therapy. * Participants must have measurable disease with at least two malignant lesions, one for disease monitoring as response to therapy and one for TIL harvest. * Age ≥18 years * Received one of the following regimens: * Anti-PD-(L)1 immu…
Part of the lymphodepleting chemotherapy given before LN-145 infusion
Part of the lymphodepleting chemotherapy given before LN-145 infusion.
Administered after LN-145 infusion as part of the treatment regimen.
Surgical removal of tumor tissue for TIL production/manufacture
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.