Beth Israel registers Phase II lifileucel TIL trial for kidney cancer with Iovance

A single new trial registration marks this week's activity.

• A Phase II single-arm study titled "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" (NCT07925333) was listed, sponsored by Beth Israel Deaconess Medical Center with Iovance Biotherapeutics, Inc. as a collaborator¹. The study is not yet recruiting, with an estimated start date of April 26, 2027 and estimated primary completion of August 1, 2029¹, and plans to enroll 10 participants¹. Patients will 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 patient¹, followed by 5 days of lymphodepleting chemotherapy before TIL infusion, using cyclophosphamide and fludarabine, followed by LN-145 infusion on Day 0 and IL-2 (aldesleukin) afterward¹. The primary outcome is Radiographic Objective Response Rate, assessed centrally per RECIST 1.1 in the efficacy evaluable population, with primary analysis performed on patients who receive TIL¹.