Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05640193

Collaborator

Iovance Biotherapeutics, Inc. (Industry)

Enrollment

Location

Arm

23.2

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Biological: Lifileucel (LN-144)	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases

Actual Study Start Date :

Nov 25, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Melanoma Brain Metastases Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.	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.

Arm

Intervention/Treatment

Experimental: Participants with Melanoma Brain Metastases

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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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