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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:January 9, 2017
End Date:June 2022
Contact:Iovance Biotherapeutics Study Team
Email:Clinical.Inquiries@iovance.com
Phone:866-565-4410

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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

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 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.
We found this trial at
19
sites
4805 Northeast Glisan Street
Portland, Oregon 97213
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Aurora, Colorado 80045
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Birmingham, Alabama 35294
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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303 East Superior Street
Chicago, Illinois 60611
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Morristown, New Jersey 07962
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New Brunswick, New Jersey 08901
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New Orleans, LA
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Pittsburgh, Pennsylvania 15232
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Tampa, Florida 33612
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Westwood, Kansas 66205
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