Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145/LN-145-S1) for the Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
2 other identifiers
interventional
64
1 country
22
Brief Summary
Multicenter, multicohort, non-randomized, prospective, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145/LN-145-S1) 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2017
CompletedFirst Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2022
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedOctober 12, 2023
September 1, 2023
5.6 years
March 14, 2017
August 4, 2023
September 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
The percentage of patients who have a confirmed complete response or partial response as assessed by the investigator per RECIST v1.1. Objective response rate (ORR) will be defined as the percentage of the patients with a confirmed complete or partial response (CR or PR),by MRI or CT scan as per RECIST 1.1 criteria. Complete response (CR), Disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size(\<10mm short axis). No new lesions. Partial response (PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion(s) and/or maintenance above the normal limits (Non-CR/Non-PD). No new lesions.
Up to 24 months
Secondary Outcomes (3)
Duration of Response
Up to 24 months
Disease Control Rate
Up to 24 months
Progression-Free Survival
Up to 24 months
Study Arms (5)
Cohort 1
EXPERIMENTALTreatment with LN-145, Generation 1 (Gen 1), non-cryopreserved TIL
Cohort 2
EXPERIMENTALTreatment with LN-145 Generation 2 (Gen 2), cryopreserved TIL
Cohort 3
EXPERIMENTALTreatment with LN-145 Generation 3 (Gen 3), cryopreserved TIL
Cohort 4
EXPERIMENTALTreatment with LN-145-S1 cryopreserved TIL
Cohort 5
EXPERIMENTALLN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Patients who have received an organ allograft or prior cell transfer therapy within the past 20 years.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
University of Alabama
Birmingham, Alabama, 35294, United States
University of California San Diego
La Jolla, California, 92093, United States
University of California, Los Angeles
Los Angeles, California, 90024, United States
University of Southern California
Los Angeles, California, 90033, United States
University of Colorado
Aurora, Colorado, 80045, United States
Christiana Care Health System
Newark, Delaware, 19718, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Kansas
Westwood, Kansas, 66205, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Louisiana State University - Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Providence Cancer Center Oncology and Hematology Care Clinic
Portland, Oregon, 97213, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
University of Washington
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 40854613DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Medical Director, Rana Fiaz
- Organization
- Iovance
Study Officials
- STUDY DIRECTOR
Iovance Biotherapeutics Medical Monitor
Iovance Biotherapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2017
First Posted
March 20, 2017
Study Start
January 9, 2017
Primary Completion
August 8, 2022
Study Completion
August 8, 2022
Last Updated
October 12, 2023
Results First Posted
October 12, 2023
Record last verified: 2023-09