Clinical Trial 18944

Cancer Type: Head & Neck
Interventions:IL-2 (Interleukin-2); LN-145; MESNA; TIL; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Christine Chung

Overview

Study Title

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

Summary

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.

Objective

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.

Inclusion Criteria

  • Must be greater than 18 years of age at the time of consent.
  • 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.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must be seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
  • Females of childbearing potential must be willing to practice an approved method of birth control starting at the time of informed consent and for 1 year after the completion of the lymphodepletion regimen.

  • 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.
  • Currently have prior therapy-related toxicities greater than Grade 1 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03, except for alopecia or vitiligo prior to enrollment.
  • Have had immunotherapy-attributable Adverse Event (AR): 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.
  • 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.
  • Have a left ventricular ejection fraction (LVEF) > Have a FEV1 (forced expiratory volume in one second) of less than or equal to 60 % of normal.