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항목
CGTCurated CoreFDAstaleApproved
lifileucel (Amtagvi, LN-144, tumor infiltrating lymphocyte)
Iovance Biotherapeutics·Polyclonal tumor neoantigens (TIL)
47 trials
Overview
Program
Amtagvi (lifileucel)
Overview
Company
Iovance Biotherapeutics
Overview
Modality
CGT
Overview
Target
Polyclonal tumor neoantigens (TIL)
Overview
Indication
Unresectable or metastatic melanoma after PD-1 blockade
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Polyclonal recognition of private neoantigens instead of one engineered receptor, so it does not depend on a single shared target.
Positioning
Known limitation
Antigen presentation loss (B2M/HLA), TIL exhaustion, and a hostile tumor microenvironment.
Positioning
Development positioning
Post-IO salvage
MoA
Mechanism
Autologous TILs already primed against the patient's tumor are expanded to therapeutic numbers, reinfused after lymphodepletion to clear regulatory cells and cytokine sinks, then supported with IL-2.
MoA
Biomarker
Tumor mutational burden and baseline tumor burden correlate with response; no required companion diagnostic.
Toxicology
Major finding
Boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary and renal impairment, and internal hemorrhage. Most toxicity comes from lymphodepletion and IL-2, not the TILs themselves.
Toxicology
CRS
Uncommon compared with CAR-T
Clinical
Safety signal
Boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary and renal impairment, and internal hemorrhage. Most toxicity comes from lymphodepletion and IL-2, not the TILs themselves.
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts