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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT05398640
• Other study ID #: IOV-EAP-401
• Status: No longer available

Study information

• Verified date: October 2023
• Source: Iovance Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma
• Unresectable Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of Louisville - Brown Cancer Center	Louisville	Kentucky
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	Washington University School of Medicine - Siteman Cancer Center	Saint Louis	Missouri
United States	HonorHealth Research and Innovation Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Iovance Biotherapeutics, Inc.

Country where clinical trial is conducted

United States,