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Trial Title:
A Study of LN-144 in People With Metastatic Melanoma to the Brain
NCT ID:
NCT05640193
Condition:
Metastatic Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
LN-144
Non-uveal melanoma
Lifileucel (LN-144)
22-322
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Lifileucel (LN-144)
Description:
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 group label:
Participants with Melanoma Brain Metastases
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Start date:
November 25, 2022
Completion date:
November 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Iovance Biotherapeutics, Inc.
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640193
http://www.mskcc.org/mskcc/html/44.cfm
