NCT02360579 · CITED IN SOURCE DOCUMENTS

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-03-25

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Disease Assessment for Objective Response Rate

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outcome · POSTED

Disease Assessment for Duration of Response

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outcome · POSTED

Disease Assessment for Disease Control Rate

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outcome · POSTED

Disease Assessment for Progression-Free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Safety Profile

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in the study: Criteria for Inclusion: 1. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV) 2. 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 3. At least one measurable target lesion, as defined by RECIST v1.1 * Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion 4. 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) 5. 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 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months 7. In the opinion of the Investigator, patients must be able to complete all study-required procedures 8. Patients must have the following hematologic parameters: * Absolute neutrophil count (ANC) ≥ 1000/mm3 * Hemoglobin (Hb) ≥ 9.0 g/dL * Platelet ≥ 100,000/mm3 9. Patients must have adequate organ function: * Serum alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN * Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula * Total bilirubin ≤ 2 mg/dL * Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL 10. 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 with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and/or had a normal colonoscopy post-immune checkpoint inhibitor treatment, by visual assessment, prior to tumor resection 11. Patients must have a washout period ≥ 28 days from prior anticancer therapy(ies) to the start of the planned NMA-LD preconditioning regimen: * Targeted therapy: MEK/BRAF or other targeted agent * Chemotherapy * Immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine * 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 v4.03 12. 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 * Approved methods of birth control are as follows: * Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal * Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner * True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable 13. 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 14. 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: 1. 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 2. Patients who have received an organ allograft or prior cell transfer therapy 3. Patients with melanoma of uveal/ocular origin 4. Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs: * NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine) * Antibiotics (ABX) of the aminoglycoside group (ie, 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 5. 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, and must be stable for ≥ 14 days prior to beginning the NMA LD preconditioning regimen 6. Patients who are on chronic systemic steroid therapy for any reason 7. 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 8. Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \[SCID\] and acquired immunodeficiency syndrome \[AIDS\]) 9. 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 10. Patients who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% 11. 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) 12. Patients who have received a live or attenuated vaccine within 28 days of beginning the NMA-LD preconditioning regimen 13. Patients who are pregnant or breastfeeding 14. Patients whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this trial 15. Patients protected by the following constraints: * Hospitalized persons without consent or persons deprived of liberty because of a judiciary or administrative decision * Adult persons with a legal protection measure or persons who cannot express their consent * Patients in emergency situations who cannot consent to participate in the trial
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
intervention Names
Biological: Lifileucel
label
Cohort 1
type
EXPERIMENTAL
description
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
intervention Names
Biological: Lifileucel
label
Cohort 2
type
EXPERIMENTAL
description
Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).
intervention Names
Biological: Lifileucel
label
Cohort 3
type
EXPERIMENTAL
description
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
intervention Names
Biological: Lifileucel
label
Cohort 4
type
EXPERIMENTAL

interventions

arm Group Labels
Cohort 1
Cohort 2
Cohort 3
Cohort 4
description
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
name
Lifileucel
other Names
LN - 144
type
BIOLOGICAL

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 220
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for Cohorts 1 \& 3 and as assessed by Independent Review Committee (IRC) per RECIST Version 1.1 for Cohorts 2 \& 4
measure
Disease Assessment for Objective Response Rate
time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months

secondary Outcomes

description
Evaluate the efficacy endpoints of duration of response (DOR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
measure
Disease Assessment for Duration of Response
time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
description
Evaluate the efficacy endpoints of disease control rate (DCR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
measure
Disease Assessment for Disease Control Rate
time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
description
Evaluate the efficacy endpoints of Progression-Free Survival by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
measure
Disease Assessment for Progression-Free Survival
time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
description
Evaluate overall survival (OS)
measure
Overall Survival
time Frame
Until death or up to 60 months
description
Incidence, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events
measure
Safety Profile
time Frame
Maximum 60 months

Full study description

brief Summary: 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.
detailed 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.

Source references

references

citation
Chesney J, Lewis KD, Kluger H, Hamid O, Whitman E, Thomas S, Wermke M, Cusnir M, Domingo-Musibay E, Phan GQ, Kirkwood JM, Hassel JC, Orloff M, Larkin J, Weber J, Furness AJS, Khushalani NI, Medina T, Egger ME, Graf Finckenstein F, Jagasia M, Hari P, Sulur G, Shi W, Wu X, Sarnaik A. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. J Immunother Cancer. 2022 Dec;10(12):e005755. doi: 10.1136/jitc-2022-005755.
pmid
36600653
type
BACKGROUND
citation
Medina T, Chesney JA, Kluger HM, Hamid O, Whitman ED, Cusnir M, Thomas SS, Wermke M, Domingo-Musibay E, Phan GQ, Kirkwood JM, Larkin J, Weber J, Graf Finckenstein F, Chou J, Gastman B, Wu X, Fiaz R, Sarnaik AA; C-144-01 Investigators. Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study. J Clin Oncol. 2025 Nov 20;43(33):3565-3572. doi: 10.1200/JCO-25-00765. Epub 2025 Jun 2.
pmid
40454684
type
BACKGROUND
citation
Kluger H, Grigoleit GU, Thomas S, Domingo-Musibay E, Chesney JA, Sanmamed MF, Medina T, Ziemer M, Whitman E, Finckenstein FG, Gastman B, Chou J, Wu X, Sulur G, Fiaz R, Qi R, Sarnaik AA. Lifileucel tumor-infiltrating lymphocyte cell therapy in patients with unresectable or metastatic mucosal melanoma after disease progression on immune checkpoint inhibitors. Cancer Commun (Lond). 2025 Oct;45(10):1229-1234. doi: 10.1002/cac2.70050. Epub 2025 Jul 22. No abstract available.
pmid
40693376
type
BACKGROUND
citation
Sarnaik AA, Hamid O, Khushalani NI, Lewis KD, Medina T, Kluger HM, Thomas SS, Domingo-Musibay E, Pavlick AC, Whitman ED, Martin-Algarra S, Corrie P, Curti BD, Olah J, Lutzky J, Weber JS, Larkin JMG, Shi W, Takamura T, Jagasia M, Qin H, Wu X, Chartier C, Graf Finckenstein F, Fardis M, Kirkwood JM, Chesney JA. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J Clin Oncol. 2021 Aug 20;39(24):2656-2666. doi: 10.1200/JCO.21.00612. Epub 2021 May 12.
pmid
33979178
type
DERIVED

Source notices and limitations

Discovery and provenance

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> <div class="pdq-content-list"><ol id="_1482"><li> A multicenter, multicohort, open-label trial (<a href="/clinicaltrials/NCT02360579">C-144-01</a> [NCT02360579]) evaluated the efficacy and safety of lifileucel in patients with unresectable or metastatic melanoma. The pivotal cohort (cohort 4) included 73 adult patient
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Melanoma Treatment (PDQ®)–Health Professional Version
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Updated: May 2, 2025
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Preserved source evidence · Not medical advice