A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
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
18 Years and up
Accepting Healthy Volunteers?
- 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.
- 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.