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항목
CGTCurated CoreFDAApproved
lifileucel (Amtagvi, LN-144, tumor infiltrating lymphocyte)
Iovance Biotherapeutics·Polyclonal tumor neoantigens (TIL)
47 trials·t½ Cell persistence, not plasma pharmacokinetics
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
Data Confidence · High
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
Only approved TIL product; opens the solid-tumor cell-therapy category.
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.
PK/PD
Half-life
Cell persistence, not plasma pharmacokinetics
PK/PD
Species
TIL persistence in blood and tumor, radiographic response duration
PK/PD
Animal (cat.)
Human
PK/PD
Experiment
PD
Toxicology
Species
Mouse
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
Selected reported efficacy
ORR 83.33%
Clinical
Reported ORR
83.33%
Clinical
Reported OS
12
Clinical
Result source
ClinicalTrials.gov NCT02111863
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT02111863
Preclinical
Animal (cat.)
Mouse