Tests lifileucel cell therapy in kidney cancer after immunotherapy stopped working

Trial details

Who runs it

Beth Israel Deaconess Medical Center

Trial code

NCT07925333

Record updated

9 November 2026

Original description

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.Read full original descriptionShow less

A Phase II Trial of Autologous Ex Vivo Expanded Tumor-Infiltrating Lymphocyte (TIL) Therapy With Lifileucel After Failure of PD-1 Blockade in Kidney Cancer.

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.

Inclusion: 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 immune checkpoint inhibitor (ICI) with or without an anti-CTLA-4 ICI or VEGF tyrosine kinase inhibitor (TKI) for treatment of advanced/metastatic disease, and experienced either (1) radiographic progression of disease while on treatment or (2) best response of stable disease after at least 6 months; Adjuvant anti-PD-(L)1 ICI after nephrectomy for localized disease and had either (1) disease recurrence while receiving adjuvant ICI or (2) disease recurrence within 6 months of the final dose of any amount of adjuvant ICI; Prior HIF2α inhibitor exposure in the adjuvant or advanced/metastatic setting is allowed but not required; Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months in the opinion of the Investigator; Participants must have adequate organ and marrow function as defined in the protocol; Patients with definitively treated brain metastases may be considered for enrollment if the patient is clinically stable for ≥ 14 days, with no lesions on follow-up imaging and no requirement for ongoing steroid treatment; Participants must have a washout period from any anticancer therapy prior to tumor harvest. The protocol contains provisions for optional use of "bridging" TKI between tumor harvest and lymphodepleting chemotherapy; Palliative radiation therapy is permitted as long as it does not involve lesions being selected for resection for TIL manufacturing, or being assessed radiographically as target lesions; Participants must have recovered from all prior anti-cancer therapy-related adverse events (AEs), as defined in the protocol; Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control; Previous surgical procedure(s) is/are permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.

Exclusion: Patients who have received an organ allograft or prior cell transfer therapy within the past 20 years that included a non-myeloablative or myeloablative chemotherapy regimen; Patients who have a history of hypersensitivity to any component of the study intervention; Patients with rapidly progressive disease or symptomatic disease requiring urgent treatment per investigator discretion; Patients who are on chronic systemic steroid therapy except for those requiring steroid therapy for management of adrenal insufficiency; Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS]); Patients with any other primary malignancy that is radiographically visible or is expected to require treatment within the next three years; Patients with symptomatic and/or untreated brain metastases; Patients who are pregnant or breastfeeding; Patients who are hypoxemic (oxygen saturation <90%) on room air at baseline or who require supplemental oxygen; Other protocol-defined inclusion/exclusion criteria may apply.

ClinicalTrials.gov NCT07925333