Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


- Must be greater than 18 years of age at the time of consent.

- Must have recurrent and/or metastatic HNSCC.

- 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).

- 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single Arm
LN-145 autologous tumor infiltrating lymphocytes
  • 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 names:
    • TIL, autologous tumor infiltrating lymphocytes

Recruiting Locations

More Details

NCT ID
NCT03083873
Status
Recruiting
Sponsor
Iovance Biotherapeutics, Inc.

Study Contact

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

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.