Study of LN-145 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck

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.

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.

- 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) indicating acute or chronic
infection may be enrolled if the viral load by polymerase chain reaction (PCR) is
undetectable with/without active treatment

- 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.