Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Pati… (NCT02360579) | Clinical Trial Compass
CompletedPhase 2
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
United States220 participantsStarted 2015-09-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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
✕
What they're measuring
1
Disease Assessment for Objective Response Rate
Timeframe: Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
. 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 \[AIDS\])