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
Brief SummaryProspective, 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
Detailed DescriptionLN-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 and Exclusion 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.
- 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.
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.