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항목
CGTCurated CoreFDAstaleApproved
tisagenlecleucel (Kymriah, tisa-cel)
Novartis·CD19
48 trials
Overview
Program
Kymriah (tisagenlecleucel)autologous CD19-directed chimeric antigen receptor (CAR) T-cells
Overview
Company
NovartisAstraZeneca
Overview
Modality
CGTCGT
Overview
Target
CD19CD19
Overview
Indication
ALL, DLBCL, FLRelapsed Non Hodgkin Lymphoma; Relapsed Adult ALL
Overview
Phase
APPROVEDPHASE_2
Overview
Status
APPROVEDRECRUITING
Overview
Content status
Curated CoreStandard Database
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · structured catalog
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedInvestigational
Positioning
Key differentiator
4-1BB persistence profile—
Positioning
Known limitation
downregulation of naïve T-cell-associated genes (SELL and CD28)—
Technology
Vector
LentivirusAAV) but is clinically still in an early developmental stage
MoA
Mechanism
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.CAR T-cell product type, and higher day 0 C-reactive protein were independently associated with lower odds of 72-hour SNI
MoA
Biomarker
CD19; measurable residual disease in ALL.biomarkers such as body composition metrics
Toxicology
Species
Mouse—
Toxicology
Animal (cat.)
Human—
Toxicology
Major finding
CRS and neurological events; hypogammaglobulinemia from B-cell aplasia.—
Toxicology
CRS
CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocol—
Clinical
Safety signal
CRS and neurological events; hypogammaglobulinemia from B-cell aplasia.—
Clinical
Program phase
APPROVEDPHASE_2
Clinical
Trial activity
No active/completed countsNo active/completed counts