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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05640193

Enrollment

Registered

2022-12-07

Start date

2022-11-25

Completion date

2027-11-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

Keywords

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

Brief 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.

Interventions

BIOLOGICALLifileucel (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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Metastatic melanoma with asymptomatic brain metastases 2. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL 3. Must be ≥ 18 years of age at time of consent 4. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months 5. Adequate hematologic parameters and organ function

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. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs 4. Symptomatic brain metastases 5. Chronic systemic steroid therapy of \> 10 mg/day 6. Active medical illness(es) that would pose increased risk for protocol participation 7. 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 8. Primary immunodeficiency 9. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD 10. Pregnant or breastfeeding 11. Patients who cannot receive gadolinium-enhanced MRI.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)	1 year	measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlexander Shoushtari, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026