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Squamous Cell Carcinoma of the Head and NeckPhase 2NCT03083873

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 study testing LN-145 and LN-145-S1 in people with Squamous Cell Carcinoma of the Head and Neck, run by Iovance Biotherapeutics, Inc. at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LN-145 and LN-145-S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
22 sitesUnited States
Study dates
9 Jan 2017to 8 Aug 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • University of Alabama

    Birmingham, Alabama, 35294

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of California San Diego

    La Jolla, California, 92093

  • University of California, Los Angeles

    Los Angeles, California, 90024

  • University of Southern California

    Los Angeles, California, 90033

  • University of Louisville

    Louisville, Kentucky, 40202

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Louisiana State University - Health Sciences Center

    New Orleans, Louisiana, 70112

  • Christiana Care Health System

    Newark, Delaware, 19718

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15213

  • Providence Cancer Center Oncology and Hematology Care Clinic

    Portland, Oregon, 97213

  • University of Washington

    Seattle, Washington, 98195

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Kansas

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: 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

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

Read the detailed description

LN-145/LN-145-S1 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 lymphodepletion preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Being tested
LN-145, LN-145-S1
Keywords
LN-145, Cell Therapy, Autologous Adoptive Cell Transfer, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2, LN-145-S1
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LN-145Biological

    Also called TIL, autologous tumor infiltrating lymphocytes

    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-S1Biological

    Also called TIL, autologous tumor infiltrating lymphocytes

    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.

Study groups in NCT03083873
Study groupRoleWhat they receive
Cohort 1ExperimentalTreatment with LN-145, Generation 1 (Gen 1), non-cryopreserved TIL
Receives: Biological: LN-145
Cohort 2ExperimentalTreatment with LN-145 Generation 2 (Gen 2), cryopreserved TIL
Receives: Biological: LN-145
Cohort 3ExperimentalTreatment with LN-145 Generation 3 (Gen 3), cryopreserved TIL
Receives: Biological: LN-145
Cohort 4ExperimentalTreatment with LN-145-S1 cryopreserved TIL
Receives: Biological: LN-145-S1
Cohort 5ExperimentalLN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment
Receives: Biological: LN-145; Biological: LN-145-S1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months

Secondary outcomes (3)

  1. Duration of Response

    To evaluate efficacy parameters such as Duration of Response (DOR) using RECIST v1.1 as assessed by the Investigator. DOR is measured from the time point at which the initial measurement criteria per RECIST v1.1 are met for a CR or PR (if response is a confirmed response), whichever response is observed first, until PD.

    Measured: Up to 24 months

  2. Disease Control Rate

    The percentage of patients who have a best overall response of complete response, partial response, or stable disease as assessed by the investigator per RECIST v1.1. The BOR of SD must be at least 4 weeks from LN-145/LN-145-S1 infusion.

    Measured: Up to 24 months

  3. Progression-Free Survival

    The time (in months) from the date of the TIL infusion to progressive disease as assessed by the Investigator using RECIST v1.1 or death due to any cause, whichever occurs earlier. Progression was defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of diameters of the target lesions and an absolute increase of at least 5 mm, and/or unequivocal progression of existing non-target lesions, and/or the appearance of 1 or more new lesions.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2017
  2. Study start9 Jan 2017
  3. Primary completion8 Aug 2022
  4. Study completion8 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03083873
Sponsor's protocol ID
C-145-03
Other IDs
2016-003446-86, 2016
Status last verified
Sep 2023
First submitted
14 Mar 2017
Last updated
12 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40854613

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LN-145 and LN-145-S1 in people with Squamous Cell Carcinoma of the Head and Neck, run by Iovance Biotherapeutics, Inc. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03083873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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