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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Metastatic Melanoma

Treatments: Biological: Lifileucel (LN-144)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05640193

22-322

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Participants with Melanoma Brain Metastases

Experimental group

Description:

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

Treatment:

Biological: Lifileucel (LN-144)