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

Sponsor

Iovance Biotherapeutics, Inc. (Industry)

Overall Status

Available

CT.gov ID

NCT05398640

Collaborator

(none)

Locations

Study Details

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	Phase
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

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Unresectable or metastatic melanoma (Stages IIIC/IIID/IV per AJCC 8th edition)
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.
May have received adjuvant PD-1/PD-L1 blocking antibody if recurred within 6 months of discontinuation of therapy or while on therapy
At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
Must be ≥ 18 years of age at time of consent
ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
Adequate hematologic parameters and organ function
There is no alternative therapy

Exclusion Criteria:

Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
Melanoma of uveal/ocular origin
History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
Symptomatic and/or untreated brain metastases, unless definitively treated and stable for ≥ 14 days prior to beginning NMA LD preparative regimen
Chronic systemic steroid therapy of > 10 mg/day
Active medical illness(es) that would pose increased risk for protocol participation
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
Primary immunodeficiency
Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Health Cancer Institute	Orlando	Florida	United States	32806
2	University of Louisville - Brown Cancer Center	Louisville	Kentucky	United States	40202
3	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065