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API CSV24행 · 2개 프로그램

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항목
CGTCurated CoreFDAstaleApproved
axicabtagene ciloleucel (Yescarta, axi-cel)
Kite / Gilead·CD19
68 trials
CGTCurated CoreFDAstaleApproved
tisagenlecleucel (Kymriah, tisa-cel)
Novartis·CD19
48 trials
Overview
Program
Yescarta (axicabtagene ciloleucel)Kymriah (tisagenlecleucel)
Overview
Company
Kite / GileadNovartis
Overview
Modality
CGTCGT
Overview
Target
CD19CD19
Overview
Indication
LBCL, FLALL, DLBCL, FL
Overview
Phase
APPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approved
Positioning
Key differentiator
Rapid manufacturing, CD28 signaling4-1BB persistence profile
Positioning
Known limitation
CD19 antigen loss, T-cell exhaustion, and hostile tumor microenvironment.downregulation of naïve T-cell-associated genes (SELL and CD28)
Positioning
Development positioning
2L+—
Technology
Vector
RetrovirusLentivirus
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.Autologous T cells transduced with lentiviral vector encoding CD19-specific CAR with 4-1BB and CD3ζ signaling domains. Engages CD19+ B cells leading to proliferation and cytotoxicity.
MoA
Biomarker
CD19 expression on lymphoma cells; CAR T expansion in blood.CD19; measurable residual disease in ALL.
Toxicology
Species
—Mouse
Toxicology
Animal (cat.)
UnknownHuman
Toxicology
Major finding
CRS, ICANS, cytopeniasCRS and neurological events; hypogammaglobulinemia from B-cell aplasia.
Toxicology
CRS
Grade ≥3 ~13%CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocol
Clinical
Safety signal
CRS, ICANS, cytopeniasCRS and neurological events; hypogammaglobulinemia from B-cell aplasia.
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts