A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144 or LN-145) in Patients With Solid Tumors

\LN-144 (Lifileucel)/LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process for the treatment of patients with advanced unresectable or metastatic melanoma, advanced squamous cell carcinoma of the head and neck, and non-small cell lung cancer. The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients in Cohort 1 and 2 will receive TIL plus pembrolizumab, and patients in Cohort 3 will receive TIL as a single therapy.

Inclusion Criteria

• Patients must be ≥18 years and ≤70 years of age at the time of consent. Enrollment of patients >70 years of age may be allowed.
• Must have a histologically confirmed unresectable or metastatic melanoma (Cohort 1), recurrent or metastatic squamous cell carcinoma of the head and neck (Cohort 2), or recurrent or metastatic non-small cell lung cancer (Cohort 3).
• Cohort 1 and Cohort 2 only: must have not received prior immunotherapy, including checkpoint inhibitors (eg, anti-PD-1/anti-PD-L1 and/or anti-CTLA-4). With the excluded prior therapies cited, patients may have received from 1 to 3 prior systemic anticancer therapies.
• Cohort 3 only: Patients with Stage III or Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, or large cell carcinoma) who have received from 1 to 3 prior systemic anticancer therapies, including checkpoint inhibitors (eg, anti-PD-1/anti-PD-L1) in the locally advanced or metastatic setting.
• Must have remaining measurable disease as defined by RECIST 1.1 following tumor resection
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Childbearing potential or their partners of childbearing potential must be willing to practice an approved method of birth control
• Must have adequate organ function.
• Must be seronegative for the human immunodeficiency virus (HIV).
• Must have provided written authorization for use and disclosure of protected health information.

Exclusion Criteria

• Patients with melanoma of uveal/ocular origin.
• Patients who have received an organ allograft or prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen.
• Patients with symptomatic and/or untreated brain metastases
• Patients who are on a systemic steroid therapy at a dose of >10mg of prednisone or equivalent a day. Short course of higher-dose steroid therapy is allowed.
• Patients who are pregnant or breastfeeding.
• Patients who have an active medical illness(es), which in the opinion of the Investigator, would pose increased risks for study participation
• Patients may not have active or prior documented autoimmune or inflammatory disorders
• Patients who have any form of primary immunodeficiency
• Patients with a history of hypersensitivity to any component of the study drugs
• Patients who have obstructive or restrictive pulmonary disease
• Patients who have had another primary malignancy within the previous 3 years
• Participation in another clinical study with an investigational product within 21 days of the initiation of nonmyeloablative lymphodepletion (NMA-LD) treatment.