Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck
NCT ID: NCT03083873
Last Updated: 2023-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2017-01-09
2022-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
Treatment with LN-145, Generation 1 (Gen 1), non-cryopreserved TIL
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Cohort 2
Treatment with LN-145 Generation 2 (Gen 2), cryopreserved TIL
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Cohort 3
Treatment with LN-145 Generation 3 (Gen 3), cryopreserved TIL
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Cohort 4
Treatment with LN-145-S1 cryopreserved TIL
LN-145-S1
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with autologous TIL (LN-145-S1) followed by IL-2 administration.
Cohort 5
LN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
LN-145-S1
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with autologous TIL (LN-145-S1) followed by IL-2 administration.
Interventions
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LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
LN-145-S1
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with autologous TIL (LN-145-S1) followed by IL-2 administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Any prior therapy directed at the malignant tumor 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 human immunodeficiency virus.
* 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
* Patients of childbearing potential and patients whose sexual partners are of childbearing potential must be willing to practice an approved method of highly effective 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 are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent). Patients receiving steroids as replacement therapy for adrenocortical insufficiency at \< 10 mg of prednisone or other steroid equivalent daily may be eligible.
* Prior therapy-related toxicities Grade ≥ 1 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03
* Patients with documented Grade ≥ 2 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 (ie, gentamicin or streptomycin; excluding those who are skin-test negative for gentamicin hypersensitivity), 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).
* 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 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.
18 Years
ALL
No
Sponsors
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Iovance Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Iovance Biotherapeutics Medical Monitor
Role: STUDY_DIRECTOR
Iovance Biotherapeutics
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California San Diego
La Jolla, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Christiana Care Health System
Newark, Delaware, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas
Westwood, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Louisiana State University - Health Sciences Center
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Morristown Medical Center
Morristown, New Jersey, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Providence Cancer Center Oncology and Hematology Care Clinic
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Ferris RL MD,, Leidner RS, Chung CH, Jimeno A, Lee SM, Sukari A, Nieva JJ, Grilley-Olson JE, Redman R, Wong SJ, Villaflor VM, Misleh J, Finckenstein FG, Chou J, Gastman B, Fiaz R, Catlett M, Yi M, Cohen EEW. Efficacy and safety of one-time autologous tumor-infiltrating lymphocyte cell therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. J Immunother Cancer. 2025 Aug 24;13(8):e011633. doi: 10.1136/jitc-2025-011633.
Provided Documents
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Document Type: Study Protocol: Version 1
Document Type: Study Protocol: Version 2
Document Type: Study Protocol: Version 3
Document Type: Study Protocol: Version 4
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003446-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C-145-03
Identifier Type: -
Identifier Source: org_study_id
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