University of Louisville | James Graham Brown Cancer Center
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Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.
Full 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.
Enrollment
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Inclusion and exclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in the study:
Criteria for Inclusion:
Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV)
Patients must have progressed following ≥ one prior systemic therapy including a programmed cell death protein-1 (PD-1) blocking antibody; and if proto-oncogene B-Raf (BRAF) V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor
At least one measurable target lesion, as defined by RECIST v1.1
At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)
Patients must be ≥ 18 years of age at the time of consent. Enrollment of patients > 70 years of age may be allowed after consultation with the Medical Monitor
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months
In the opinion of the Investigator, patients must be able to complete all study-required procedures
Patients must have the following hematologic parameters:
Patients must have adequate organ function:
Patients must have recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v4.03), except for alopecia or vitiligo, prior to Enrollment (tumor resection)
Patients must have a washout period ≥ 28 days from prior anticancer therapy(ies) to the start of the planned NMA-LD preconditioning regimen:
Patients of childbearing potential or their partners of childbearing potential 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 receiving the last protocol-related therapy
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
Patients have provided written authorization for use and disclosure of protected health information
Criteria for Exclusion:
Patients who meet any of the following criteria are not eligible for participation in this study:
Patients who have been shown to be BRAF mutation positive (V600), but have not received prior systemic therapy with a BRAF inhibitor alone or a BRAF inhibitor in combination with a MEK inhibitor
Patients who have received an organ allograft or prior cell transfer therapy
Patients with melanoma of uveal/ocular origin
Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs:
Patients with symptomatic and/or untreated brain metastases (of any size and any number)
Patients who are on chronic systemic steroid therapy for any reason
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 system
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 documented forced expiratory volume in 1 second (FEV1) of ≤ 60%
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 non-melanoma skin cancer that has been adequately treated)
Patients who have received a live or attenuated vaccine within 28 days of beginning the NMA-LD preconditioning regimen
Patients who are pregnant or breastfeeding
Patients whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this trial
Patients protected by the following constraints:
Primary purpose
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178 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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