A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma

Recruiting now · Phase 1

Conditions studied: Uveal Melanoma, Melanoma, Metastatic Uveal Melanoma, Metastatic Melanoma

In brief

This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.

Key facts

Study ID

NCT05607095

Run by

Memorial Sloan Kettering Cancer Center

People needed

40

Starts

2022-11-01

Expected to finish

2027-05-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.
• o Patients will be eligible regardless of the number of prior systemic therapies received.
• Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy
• Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure
• Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy
• Patients who refuse standard of care chemotherapy will be eligible
• Cohort 3: Must have a confirmed diagnosis of unresectable or metastatic angiosarcoma that is refractory to at least 1 prior line of systemic therapy
• Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure
• Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy
• Patients who refuse standard of care chemotherapy will be eligible
• 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:
• Absolute neutrophil count (ANC) ≥ 1000/mm3
• Hemoglobin (Hb) ≥ 9.0 g/dL
• Platelet ≥ 100,000/mm\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the ICF and continuing through the Screening Period
• Patients must have adequate organ function:
• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 × ULN); patients with liver metastasis ≤ 5 × ULN
• Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula at Screening
• Total bilirubin ≤ 2 mg/dL
• Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL
• Patients must be seronegative for the following:
• Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies

You may not qualify if…

• 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/LN-145 or other study drugs:
• NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)
• Proleukin®, aldesleukin, IL-2
• 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/LN-145 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
• 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 ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias must have a cardiac stress test.
• Patients with any irreversible wall movement abnormalities are excluded.
• 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:
• 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.
• 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.
• No other active, concurrent malignancy that requires ongoing systemic treatment (e.g. indolent prostate) or interferes with radiographic assessment of response as determined by the investigator. Exceptions may allow for adjuvant NED cancers undergoing hormone-based therapy assuming the other eligibility criteria are met and the PI affirms the hormonal agent would not change the response.
• 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.

Where it is running

• Memorial Sloan Kettering Westchester — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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