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

Phase 1

Active, not recruiting

• Conditions: Metastatic Melanoma
• Interventions: Biological: Lifileucel (LN-144)

• Registration Number: NCT05640193
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Study Timeline

• Study Start: 2022-11-25
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with Melanoma Brain Metastases	Lifileucel (LN-144)	Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States