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About
This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.
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Inclusion criteria
Must have a confirmed diagnosis of metastatic Uveal Melanoma.
One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).
Patients must be ≥ 18 years of age at the time of consent.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.
Patients must have the following hematologic parameters:
Patients must have adequate organ function:
Patients must be seronegative for the following:
Patients who are HSV immunoglobulin M (IgM) or PCR assay positive will need to receive appropriate treatment and become IgM or PCR assay negative prior to starting the NMA-LD pre-conditioning regimen
Anyone with prior COVID-19 infection must be asymptomatic for >30 days prior to NMA-LD.
Patients must have a washout period ≥ 28 days (or 5 half-lives for oral medications) from prior anti-cancer therapy(ies) to the start of the planned NMA-LD pre-conditioning regimen.
Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 5.0.
Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v 5.0), except for alopecia or vitiligo, prior to enrollment.
Previous surgical procedure(s) is/are permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.
Patients of childbearing potential (or female partners of male participants) must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after their last dose of IL-2. Approved methods of birth control are as follows:
Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.
Exclusion criteria
Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.
Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs:
Patients with symptomatic brain metastases (of any size and any number).
o Patients with definitively treated brain metastases may be considered for enrollment, if, prior to tumor resection for TIL, the patient is clinically stable for ≥ 14 days, there are no symptomatic brain lesions, and that the patient does not require ongoing corticosteroid treatment.
Patients who are on chronic systemic immunosuppressive therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily. Transient use of steroids, e.g. in the perioperative period, is not an exclusion.
Patients who are pregnant or breastfeeding.
Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.
Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS]).
Patients who have a left ventricular ejection fraction (LVEF) <45% or New York Heart Association (NYHA) functional classification > Class 1.
Patients who have a smoking history or signs or symptoms of obstructive or restrictive pulmonary disease and have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% of predicted normal:
Patients who have had another primary malignancy within the previous three (3) years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated).
Active, uncontrolled systemic infections, including COVID-19, within 30 days of surgery or NMA-LD. An uncomplicated bacterial UTI treated successfully with symptom resolution is not an exclusion.
Participation in another clinical study with an investigational product within 21 days of the initiation of NMA-LD.
Eligibility Designation for Lymphodepletion
Patients meeting eligibility criteria above between Day -21 and Day -8 prior to the planned initiation of lifileucel will be enrolled to the therapeutic portion of the protocol.
All patients' eligibility criteria, including repeating cardiopulmonary function tests as necessary, will be reassessed within several days prior to the scheduled lymphodepletion in all cases.
Prior to beginning the NMA-LD preparative regimen the following requirements must be met:
Subsequent delays of lymphodepletion up to 14 days due to logistical issues such as production of lifileucel and/or major weather events will not constitute protocol violations and out of window assessments will not need to be repeated unless there is a change in clinical status.
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Central trial contact
Adam Schoenfeld, MD; Alexander Shoushtari, MD
Data sourced from clinicaltrials.gov
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