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

NCT05640193 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 22-322
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Melanoma

Keywords

LN-144; Non-uveal melanoma; Lifileucel (LN-144); 22-322

Outcome Measures

Primary Outcomes (1)

• Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)

  measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion

  1 year

Study Arms (1)

Participants with Melanoma Brain Metastases

EXPERIMENTAL

Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.

Biological: Lifileucel (LN-144)

Interventions

Lifileucel (LN-144) BIOLOGICAL

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.

Participants with Melanoma Brain Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic melanoma with asymptomatic brain metastases
• 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

You may not qualify if:

• 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)
• History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
• Symptomatic brain metastases
• 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
• Patients who cannot receive gadolinium-enhanced MRI.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Iovance Biotherapeutics, Inc.: collaborator
• Stanford University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Melanoma

Interventions

lifileucel

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases

Study Officials

• Alexander Shoushtari, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: November 25, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)