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 Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (LION)

Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Inclusion Criteria:
• Must have persistent, recurrent or metastatic HNSCC; histologic documentation of the primary tumor is required via the pathology report.
• Must have had at least 1 prior systemic chemotherapeutic regimen for management of persistent, recurrent or metastatic HNSCC. Patients must not have any curative therapy options, or be intolerant of, or decline standard of care therapy for persistent, recurrent or metastatic disease.
• Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least 21 days prior to tumor resection for preparing TIL therapy.

Exclusion Criteria:
• Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent) within 28 days prior to Visit 2.
• Patients who currently have prior therapy-related toxicities greater than Grade 1 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03; (see Appendix Section 16.4), except for alopecia or vitiligo prior to enrollment.
• Patients who have had immunotherapy-attributable AE: which led to discontinuation, or have had an ophthalmologic or neurologic AE of any grade, or actively receiving any immunosuppressive agents for the treatment of toxicity related to prior immunotherapy.
• Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous immunotherapy within six months from screening.
• History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or IL-2.
• Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
• Have any form of primary immunodeficiency, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
• Diagnosis of end-stage renal disorder requiring hemodialysis.
• Patients who have a left ventricular ejection fraction (LVEF) < 45%.
• Patients who have a FEV1 (forced expiratory volume in one second) of less than or equal to 60 % of normal.
Phase II
Oral, Head and Neck
Rom Leidner, M.D.
Iovance Biotherapeutics (formerly LION Biotechnologies)
George Morris
  • Oncology and Hematology Care Eastside