Expanded Access Program for Lifileucel (LN-144) in Patients with Advanced Melanoma
Sponsor: Iovance Biotherapeutics, Inc.
ClinicalTrials ID:NCT05398640
This program offers access to a treatment called Lifileucel (LN-144) for patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This program provides access to Lifileucel (LN-144), a treatment for patients with advanced melanoma that cannot be removed by surgery or has spread. The treatment involves using a patient's own immune cells, which are grown and modified in a lab over 22 days, to help fight the cancer. Patients will receive a one-time infusion of these cells, along with other medications to prepare the body and support the treatment.
Description
Lifileucel (LN-144) is a type of cell therapy that uses a patient's own immune cells, called Tumor Infiltrating Lymphocytes (TILs), to target and fight melanoma. The process involves collecting these cells from the patient, growing and modifying them in a lab, and then infusing them back into the patient. This is done after a preparatory treatment to get the body ready, followed by a short course of a medication called IL-2 to help the cells work better. The goal is to provide a new treatment option for patients with advanced melanoma who have limited alternatives.
Eligibility Criteria
Inclusion Criteria
- Have advanced melanoma that cannot be surgically removed or has spread (Stage IIIC/IIID/IV).
- Have tried 1-4 previous treatments, including PD-1/PD-L1 therapies, without success or had to stop due to side effects.
- May have had PD-1/PD-L1 therapy after surgery if the cancer returned within 6 months.
- Have at least one tumor that can be removed to collect cells for the treatment.
- Be 18 years or older.
- Be in good general health with a life expectancy of at least 3 months.
- Have good blood and organ function.
- No other treatment options available.
Exclusion Criteria
- Have had an organ transplant (except kidney) or previous cell therapies like TIL or CAR-T.
- Have ongoing moderate to severe side effects from past immunotherapy (except certain conditions like vitiligo).
- Have melanoma that started in the eye.
- Have allergies to any part of the treatment.
- Have untreated or unstable brain tumors.
- Are on high-dose steroid therapy.
- Have other serious medical conditions that increase risk.
- Must test negative for syphilis and HIV; if positive for hepatitis B, must have undetectable viral load.
- Have a primary immune deficiency.
- Have received a live vaccine within 28 days before starting treatment.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HonorHealth | 85258 | Scottsdale | Arizona |
| Orlando Health Cancer Institute | 32806 | Orlando | Florida |
| Northside Hospital | 30342 | Atlanta | Georgia |
| The University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| University of Louisville - James Graham Brown Cancer Center | 40202 | Louisville | Kentucky |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Washington University - Barnes Jewish Hospital | 63110 | Saint Louis | Missouri |
| MD Anderson Cancer Center at Cooper | 08103 | Camden | New Jersey |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.