NCT05640193

A Study of LN-144 in People With Metastatic Melanoma to the Brain

Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.

Detailed description

Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. 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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Lifileucel (LN-144)	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.

Timeline

• Start date: 2022-11-25
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-12-07
• Last updated: 2025-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study