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항목
CGTCurated CoreFDAApproved
axicabtagene ciloleucel (Yescarta, axi-cel)
Kite / Gilead·CD19
68 trials·t½ CAR T expansion peak ~7–14 days post-infusion; persistence months in responders
Overview
Program
Yescarta (axicabtagene ciloleucel)
Overview
Company
Kite / Gilead
Overview
Modality
CGT
Overview
Target
CD19
Overview
Indication
LBCL, FL
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
Rapid manufacturing, CD28 signaling
Positioning
Known limitation
CD19 antigen loss, T-cell exhaustion, and hostile tumor microenvironment.
Positioning
Development positioning
First mover in CD19 CAR-T LBCL
Technology
Vector
Retrovirus
MoA
Mechanism
Autologous T cells transduced with a retroviral vector encoding an anti-CD19 CAR (scFv + CD28 + CD3ζ). CAR T cells expand in vivo, recognize CD19 on B cells, and mediate cytotoxic killing.
MoA
Biomarker
CD19 expression on lymphoma cells; CAR T expansion in blood.
PK/PD
Half-life
CAR T expansion peak ~7–14 days post-infusion; persistence months in responders
PK/PD
Species
resistance, toxicity, and precision strategies., CAR T copy number in blood, B-cell aplasia
PK/PD
Animal (cat.)
Unknown
PK/PD
Experiment
pharmacodynamic
Toxicology
Species
resistance, toxicity, and precision strategies.
Toxicology
Animal (cat.)
Unknown
Toxicology
Major finding
CRS, ICANS, cytopenias
Toxicology
CRS
Grade ≥3 ~13%
Clinical
Safety signal
CRS, ICANS, cytopenias
Clinical
Selected reported efficacy
ORR 92%
Clinical
Reported ORR
94%
Clinical
Reported PFS
40.2
Clinical
Reported OS
NA
Clinical
Result source
ClinicalTrials.gov NCT03105336
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03105336