Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma

Exclusion Criteria

• •Patients who have received an organ allograft or prior cell transfer therapy within the past 20 years that included a non-myeloablative or myeloablative chemotherapy regimen.
• •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:
• •* NMA-LD preparative regimen (cyclophosphamide, mesna, and fludarabine),
• •* Proleukin®, aldesleukin, IL-2,
• •* Pembrolizumab,
• •* Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity,
• •* Any component of the LN-144 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
• •Patients with symptomatic and/or untreated brain metastases (of any size and any number).
• •Patients who are on chronic systemic steroid 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.
• •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 must have a negative syphilis assay (per local standard, e.g., rapid plasma reagin \[RPR\], venereal disease research laboratory \[VDRL\]) and be seronegative for the human immunodeficiency virus (HIV1 and HIV2 antibody titers). Patients with positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) or hepatitis C virus (anti-HCV) indicating acute or chronic infection must have the corresponding polymerase chain reaction (PCR) assay; patients may be enrolled if the viral load by PCR is undetectable with/without active treatment. Additional serology testing may be required depending on local prevalence of certain viral exposures
• •Patients who have any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease \[SCID\] and acquired immunodeficiency syndrome \[AIDS\])
• •Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.
• •Participant has an LVEF \< 45% and is New York Heart Association (NYHA) Class 1. For participants ≥ 60 years of age OR who have a history of clinically relevant cardiac disease, no irreversible wall movement abnormality is demonstrated on a cardiac stress test (or equivalent local standard stress test). Participants with an abnormal cardiac stress test may be considered for study participation if they have adequate ejection fraction and cardiology clearance with approval of the Investigator.
• •Patients who have obstructive or restrictive pulmonary disease and have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% of predicted normal:
• •* If a patient is not able to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary function.,
• •* Patients who are unable to walk a distance of at least 80% predicted for age and sex or demonstrates evidence of hypoxia at any point during the test (SpO2 \< 90%) are excluded.
• •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; non-melanoma skin cancer that has been adequately treated; or other cancers that in the opinion of the investigator do not place the subject at a significantly higher risk).
• •Active infections, including COVID-19, within 30 days
• •Participated in another clinical study with an investigational product within 21 days of the initiation of treatment.