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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05640193
• Other study ID #: 22-322
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 25, 2022
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Iovance Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center