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A Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-145) followed by IL-2 in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to find out if an investigational product called LN-145 is safe to give to participants with recurrent and/or metastatic head and neck cancer and if processing tumors to obtain cells in a central lab works.
Primary Objectives: - To evaluate the safety and tolerability of lymphodepletion, LN-145, and IL-2 in patients with recurrent and/or metastatic HNSCC. - To evaluate the efficacy of therapy using the overall response rate (ORR) in patients with recurrent and/or metastatic HNSCC. Secondary Objectives: - To evaluate other efficacy parameters such as complete response (CR) rate, the duration of response (DOR), progression-free survival (PFS), and overall survival (OS) in patients with recurrent and/or metastatic HNSCC. Exploratory Objectives: - To explore persistence of TILs and immune correlates of response, survival, toxicity of the treatment.
IL-2 (Interleukin-2); LN-145 (); LN-145-S1 (); MESNA (); TIL (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)