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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 Cervical Carcinoma
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 cervical cancer and if processing tumors to obtain cells in a central lab works. LN-145 is also called tumor infiltrating lymphocytes (TILs). TILs are generated by processing the patient¿s own tumor in a lab to extract and grow specialized white cells called lymphocytes that may attack their tumor. LN-145 is an investigational drug. Investigational means that it has not been approved by the Food and Drug Administration (FDA). Other drugs used in this study although they may be approved for other conditions may be considered investigational in this study.
Primary Objectives: - To evaluate the safety and tolerability of lymphodepletion, LN-145, and IL-2 in patients with recurrent and/or metastatic cervical carcinoma. - To evaluate the efficacy of therapy using the overall response rate (ORR) in patients with recurrent and/or metastatic cervical carcinoma. 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 cervical carcinoma. Exploratory Objectives: - To explore persistence of TILs and immune correlates of response, survival, toxicity of the treatment.
Fluconazole (); IL-2 (Interleukin-2); LN-145 (); MESNA (); Neupogen (filgrastim); Pembrolizumab (Keytruda); cyclophosphamide (); cytoxan (cyclophosphamide); filgrastim (); fludarabine (Fludarabine phosphate)
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