Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma

• ClinicalTrials.gov Identifier: NCT05398640
• Expanded Access Status: No longer available
• First Posted: June 1, 2022
• Last Update Posted: October 12, 2023
• Sponsor: Iovance Biotherapeutics, Inc.
• Information provided by (Responsible Party): Iovance Biotherapeutics, Inc.

Study Description

Brief Summary:

This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.

Condition or disease	Intervention/treatment
Unresectable Melanoma; Metastatic Melanoma	Biological: Lifileucel

Detailed Description:

Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process for the treatment of patients with advanced melanoma. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.

Study Design

• Study Type: Expanded Access
• Expanded Access Type: Intermediate-size Population, Treatment IND/Protocol

See clinical trials of the intervention/treatment in this expanded access record.

• Official Title: An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL; LN-144), for Patients With Unresectable or Metastatic Melanoma

Interventions

Intervention Details:

• Biological: Lifileucel
  A portion of the patient's tumor is resected and serves as the starting material for manufacturing lifileucel. After preparative NMA-LD, patients are infused with their autologous TIL (lifileucel), followed by a short course of high-dose IL-2.
  Other Name: LN-144

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

Inclusion Criteria:

1. Unresectable or metastatic melanoma (Stages IIIC/IIID/IV per AJCC 8th edition)
2. Progressed on or did not achieve a response or were intolerant due to toxicity following 1-4 prior lines of systemic therapy including PD-1/ PD-L1 blocking antibody.
3. May have received adjuvant PD-1/PD-L1 blocking antibody if recurred within 6 months of discontinuation of therapy or while on therapy
4. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
5. Must be ≥ 18 years of age at time of consent
6. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
7. Adequate hematologic parameters and organ function
8. There is no alternative therapy

Exclusion Criteria:

1. Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
2. Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
3. Melanoma of uveal/ocular origin
4. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
5. Symptomatic and/or untreated brain metastases, unless definitively treated and stable for ≥ 14 days prior to beginning NMA LD preparative regimen
6. Chronic systemic steroid therapy of > 10 mg/day
7. Active medical illness(es) that would pose increased risk for protocol participation
8. Must have negative syphilis assay and be seronegative for HIV, positive serology for HBV must have corresponding PCR assay and may be enrolled if viral load by PCR is undetectable
9. Primary immunodeficiency
10. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
11. Pregnant or breastfeeding

Contacts and Locations

Locations

United States, Arizona

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, United States, 85258

United States, Florida

Orlando Health Cancer Institute

Orlando, Florida, United States, 32806

United States, Kentucky

University of Louisville - Brown Cancer Center

Louisville, Kentucky, United States, 40202

United States, Missouri

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

United States, Tennessee

The University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Sponsors and Collaborators

Iovance Biotherapeutics, Inc.

More Information

• Responsible Party: Iovance Biotherapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05398640
• Other Study ID Numbers: IOV-EAP-401
• First Posted: June 1, 2022
• Last Update Posted: October 12, 2023
• Last Verified: October 2023

Keywords provided by Iovance Biotherapeutics, Inc.:

LN-144; Lifileucel; Adoptive Cell Therapy; Cell Therapy; Tumor Infiltrating Lymphocytes; TIL; Immunotherapy; Melanoma; Cutaneous Melanoma; Mucosal Melanoma; Acral Melanoma

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases