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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05640193
Recruitment Status : Active, not recruiting
First Posted : December 7, 2022
Last Update Posted : March 7, 2024
Sponsor:
Collaborator:
Iovance Biotherapeutics, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy
Actual Study Start Date : November 25, 2022
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB) [ Time Frame: 1 year ]
    measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05640193


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Iovance Biotherapeutics, Inc.
Investigators
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Principal Investigator: Alexander Shoushtari, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05640193    
Other Study ID Numbers: 22-322
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
LN-144
Non-uveal melanoma
Lifileucel (LN-144)
22-322
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases