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Trial record 1 of 1 for:    NCT03083873
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Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck

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ClinicalTrials.gov Identifier: NCT03083873
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Iovance Biotherapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: LN-145 Biological: LN-145-S1 Phase 2

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 lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
Treatment with LN-145, Generation 1 (Gen 1), non-cryopreserved TIL
Biological: 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.
Other Name: TIL, autologous tumor infiltrating lymphocytes

Experimental: Cohort 2
Treatment with LN-145 Generation 2 (Gen 2), cryopreserved TIL
Biological: 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.
Other Name: TIL, autologous tumor infiltrating lymphocytes

Experimental: Cohort 3
Treatment with LN-145 Generation 3 (Gen 3), cryopreserved TIL
Biological: 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.
Other Name: TIL, autologous tumor infiltrating lymphocytes

Experimental: Cohort 4
Treatment with LN-145-S1 cryopreserved TIL
Biological: 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 Name: TIL, autologous tumor infiltrating lymphocytes

Experimental: Cohort 5
LN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment
Biological: 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.
Other Name: TIL, autologous tumor infiltrating lymphocytes

Biological: 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 Name: TIL, autologous tumor infiltrating lymphocytes




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to 24 months ]
    To evaluate the efficacy of LN-145/LN-145-S1 in patients with recurrent and/or metastatic HNSCC based on the objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such as Duration of Response (DOR) using RECIST v1.1 as assessed by the Investigator

  2. Disease Control Rate [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such as Disease Control Rate (DCR) using RECIST v1.1 as assessed by the Investigator

  3. Progression-Free Survival [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such as Progression-Free Survival (PFS) using RECIST v1.1 as assessed by the Investigator

  4. Overall Survival [ Time Frame: Up to 36 months ]
    To evaluate Overall Survival (OS) in patients with recurrent and/or metastatic HNSCC

  5. Safety Profile as Assessed by Incidence of Adverse Events [ Time Frame: Up to 24 months ]
    To characterize the safety profile of LN-145/LN-145-S1 in patients with metastatic and/or recurrent HNSCC



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083873


Contacts
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Contact: Iovance Biotherapeutics Study Team 866-565-4410 Clinical.Inquiries@iovance.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Iovance Biotherapeutics, Inc.
Investigators
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Study Director: Iovance Biotherapeutics Medical Monitor Iovance Biotherapeutics

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Responsible Party: Iovance Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03083873    
Other Study ID Numbers: C-145-03
2016-003446-86 ( EudraCT Number )
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iovance Biotherapeutics, Inc.:
LN-145
Cell Therapy
Autologous Adoptive Cell Transfer
Autologous Adoptive Cell Therapy
Cellular Immuno-therapy
Tumor Infiltrating Lymphocytes
TIL
IL-2
LN-145-S1
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site