Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Status: Active

Description

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel) / LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of malignancy of their receptive histologies: unresectable or metastatic melanoma (Cohort 1A), advanced recurrent or metastatic squamous cell carcinoma of the head and neck (Cohort 2A), or Stage III or Stage IV non-small cell lung cancer (Cohorts 3A and 3B).
  • Cohorts 1A, 2A, and 3A only: If previously treated, patients must have progressed on or after most recent therapy. Cohorts 1A, 2A, and 3A may have received up to 3 prior systemic anticancer therapies
  • Cohort 3B only: Patients with Stage III or Stage IV NSCLC who have previously received systemic therapy with CPIs (eg, anti-PD-1/anti-PD-L1) as part of ≤ 3 prior lines of systemic therapy. Patients must have radiographically confirmed progression on or after most recent therapy.
  • Must have at least 1 resectable lesion
  • Must have a remaining measurable disease as defined by RECIST 1.1 following tumor resection
  • Must be ≥18 years at the time of consent.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and an estimated life expectancy of ≥ 3 months
  • Patient of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after recieving all protocol-related therapy.

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 within the past 20 years.
  • Patients with symptomatic and/or untreated brain metastases
  • Patients who are on a systemic steroid therapy within 21 days of enrollment.
  • 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 received a live or attenuated vaccination within 28 days prior to the start of treatment
  • Patients who have any form of primary immunodeficiency
  • Patients with a history of hypersensitivity to any component of the study drugs
  • Patients who have a left ventricular ejection fraction (LVEF) > 45% or who are New York Heart Association Class II or higher
  • Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 ≤ 60% of predicted normal
  • 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 treatment.

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Lia Etheridge
Phone: 310-825-7174
Email: LEtheridge@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Gina Tse
Phone: 323-865-0514
Email: tse_g@med.usc.edu
San Diego
University of California San Diego
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Approved
Name Not Available

Trial Objectives and Outline

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 1A, Cohort 2A, and Cohort 3A will receive TIL plus pembrolizumab. Patients in Cohort 3B will receive TIL as a single therapy.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Iovance Biotherapeutics, Inc.

Trial IDs

Primary ID IOV-COM-202
Secondary IDs NCI-2018-01950, 2018-001608-12
Clinicaltrials.gov ID NCT03645928