A Phase 2 Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

T
Theodore Logan, MD

Primary Investigator

Overview

Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) with Lifileucel infusion (LN-144) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA-LD) preparative regimen.

Description

Lifileucel is an autologous adoptive cell transfer therapy that utilizes a TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with metastatic melanoma. The adoptive cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preconditioning regimen, prior to infusion of autologous TIL, followed by the administration of a regimen of IL-2.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Metastatic Melanoma,Metastatic Melanoma
  • Age: Between 18 Years - 70 Years
  • Gender: All

Inclusion Criteria
Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV)
Patients must have no other therapy options that are expected to have significant benefit in the opinion of the Investigator
In the opinion of the Investigator, patient must be able to complete all study-required procedures
Patients of childbearing potential or their partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after receiving last protocol-related therapy
Patients must have adequate organ function
Exclusion Criteria
Patients positive for the human immunodeficiency virus (HIV) antibody, hepatitis B antigens, or hepatitis C antibody or antigen
Patients with melanoma of uveal/ocular origin
Patients who have received an organ allograft or prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen
Patients with symptomatic and/or untreated brain metastases (of any size and any number)
Patients with definitively treated brain metastases may be considered for enrollment after discussion with the Medical Monitor, and must be stable for greater than or equal to 2 weeks prior to the start of NMA-LD
Patients who are pregnant or breastfeeding
Patients who are on a systemic steroid therapy at a dose of > 10 mg of prednisone or equivalent per day
Patients who have active medical illness(es) that in the opinion of the Investigator would pose increased risk for study participation that may include active systemic infections, such as syphilis, or any other infections requiring antibiotics, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system
Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] or acquired immunodeficiency syndrome [AIDS])
Patients who have a history of hypersensitivity to any component or excipient of the TIL therapy and other study drugs
Patients who have had another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder, localized prostate cancer and nonmelanoma skin cancer that has been adequately treated)
Patients who have been shown to be BRAF mutation positive (V600), but have not received prior systemic therapy with a BRAF-directed kinase inhibitor
Patients who have received a live or attenuated vaccine within 28 days of the start of NMA-LD
Patients whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this trial


Additional Information:
Participants will not be paid for their participation.

Updated on 09 Mar 2024. Study ID: 1803613047 (C-144-01)

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