Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Details

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.

Keywords

Squamous Cell Carcinoma of the Head and Neck LN-145 Cell Therapy Autologous Adoptive Cell Transfer Autologous Adoptive Cell Therapy Cellular Immuno-therapy Tumor Infiltrating Lymphocytes TIL IL-2 Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms

Eligibility

For people ages 18 years and up

  • 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 28 days prior to lymphodepletion
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must be seronegative for the HIV antibody,
  • Female patients 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 have received prior cell therapy, except for prior LN-145.
  • Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent).
  • 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 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, IL-2., or aminoglycosides.
  • Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
  • Patients with symptomatic and/or untreated brain metastases.
  • 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 or walk a distance less than 80% predicted in a 6-min walk test or demonstrate evidence of hypoxia during that test.

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Iovance Biotherapeutics, Inc.
ID
NCT03083873
Phase
Phase 2
Study Type
Interventional
Last Updated
June 27, 2018