Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
NCT02360579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-03-25
Summary
Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.
Conditions
Interventions
- BIOLOGICAL
-
Lifileucel
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Sponsors & Collaborators
-
Iovance Biotherapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Iovance Biotherapeutics Medical Monitor · Iovance Biotherapeutics, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-24
- Primary Completion
- 2024-10-24
- Completion
- 2024-10-24
- FDA Drug
- Yes
Countries
- United States
- France
- Germany
- Hungary
- Italy
- Spain
- Switzerland
- United Kingdom
Study Locations
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