Study of LN-145 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck

Status: Active

Description

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

Eligibility Criteria

Inclusion Criteria

  • Must be greater than 18 years of age at the time of consent.
  • Must have recurrent and/or metastatic, squamous cell carcinoma of the head and neck (both HPV-positive and -negative)
  • Must have at least 1 lesion that is resectable for TIL generation.
  • Must have measurable disease as defined by RECIST v1.1 following the surgical resection.
  • Must have received at least 1 and no more than 3 lines of prior systemic immunotherapy and/or chemotherapeutic treatments for HNSCC.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must be seronegative for the HIV antibody.
  • Patients seropositive for hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), or hepatitis C virus (anti-HCV) indicating acute or chronic infection may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment
  • Male and 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 study treatment regimen.

Exclusion Criteria

  • Patients who have received an organ allograft or prior cell transfer therapy, except for prior LN-145.
  • Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent). A short course of higher dose steroid therapy is allowed.
  • Patients who currently have prior therapy-related toxicities greater than Grade 1 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03; except for neuropathy, dysphagia, alopecia or vitiligo prior to tumor resection.
  • Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous immunotherapy within six months from screening.
  • Patients who have a contraindication to or history of hypersensitivity reaction to cyclophosphamide, mesna, fludarabine, IL-2, antibiotics of the aminoglycoside group, any component of the TIL infusion product formulation including dimethylsulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
  • 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 or acquired immunodeficiency syndrome, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
  • Diagnosis of end-stage renal disease requiring hemodialysis.
  • Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association (NYHA) Class 2 or higher.
  • Patients who have a forced expiratory volume in one second (FEV1) of less than 60% of predicted normal; or walk a distance less than 80% predicted in a 6-minute walk test or demonstrate evidence of hypoxia at any point during the test.
  • Patients who have had another primary malignancy within the previous 3 years.
  • Patients who are pregnant, parturient, or breastfeeding women.
  • Patients who have received a live or attenuated vaccine within 28 days of the NMA-LD regimen.
  • Patients whose cancer requires immediate treatment or who would otherwise suffer a disadvantage by participating in this study.

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Lisle Marie Nabell
Phone: 205-934-3061
Email: Lnabell@uabmc.edu

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: Gustavo Zentino
Phone: 310-794-8582
Email: gzetino@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Gina Tse
Phone: 323-865-0514
Email: tse_g@med.usc.edu
San Diego
University of California San Diego
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Approved
Contact: Lynne McCranor
Phone: 317-278-4712
Email: lmccrano@iupui.edu

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: In review
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Iovance Biotherapeutics, Inc.

Trial IDs

Primary ID C-145-03
Secondary IDs NCI-2017-00925, 2016-003446-86
Clinicaltrials.gov ID NCT03083873