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 persistent, recurrent or metastatic HNSCC; histologic documentation of the
primary tumor is required via the pathology report.

- Must have had at least 1 prior systemic chemotherapeutic regimen for management of
persistent, recurrent or metastatic HNSCC. Patients must not have any curative therapy
options, or be intolerant of, or decline standard of care therapy for persistent,
recurrent or metastatic disease.

- Any prior therapy directed at the malignant tumor, including radiation therapy,
chemotherapy, biologic/targeted agents and immunologic agents 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 HIV antibody,

- 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 lymphodepletion regimen.

Exclusion Criteria:

- Patients who have received prior cell therapy, except for prior LN-145.

- Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or
equivalent).

- Patients who currently have prior therapy-related toxicities greater than Grade 1
according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03; (see Appendix
Section 16.4), except for alopecia or vitiligo prior to enrollment.

- Patients with documented Grade 2 or greater diarrhea or colitis as a result of
previous immunotherapy within six months from screening.

- History of severe immediate hypersensitivity reaction to cyclophosphamide,
fludarabine, IL-2., or aminoglycosides.

- 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 immunodeficiency, such as severe combined immunodeficiency
disease or acquired immune deficiency syndrome (AIDS).

- Diagnosis of end-stage renal disorder requiring hemodialysis.

- Patients who have a left ventricular ejection fraction (LVEF) < 45%.

- Patients who have a FEV1 (forced expiratory volume in one second) of less than or
equal to 60 % of normal or walk a distance less than 80% predicted in a 6-min walk
test or demonstrate evidence of hypoxia during that test.

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

Montefiore Medical Center
Bronx, New York 10467

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.