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API CSV24행 · 3개 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
CGTCurated CoreFDAstaleApproved
ciltacabtagene autoleucel (Carvykti, cilta-cel, LCAR-B38M, JNJ-68284528)
Johnson & Johnson / Legend Biotech·BCMA
29 trials
Overview
Program
Yescarta (axicabtagene ciloleucel)Kymriah (tisagenlecleucel)Carvykti (ciltacabtagene autoleucel)
Overview
Company
Kite / GileadNovartisJohnson & Johnson / Legend Biotech
Overview
Modality
CGTCGTCGT
Overview
Target
CD19CD19BCMA
Overview
Indication
LBCL, FLALL, DLBCL, FLRelapsed or refractory multiple myeloma
Overview
Phase
APPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedFDA approved
Positioning
Key differentiator
Rapid manufacturing, CD28 signaling4-1BB persistence profileDual-epitope BCMA binding raises avidity and appears to sustain CAR-T persistence longer than single-domain designs.
Positioning
Known limitation
CD19 antigen loss, T-cell exhaustion, and hostile tumor microenvironment.downregulation of naïve T-cell-associated genes (SELL and CD28)BCMA loss or biallelic deletion, soluble BCMA shedding, T-cell exhaustion, and immunosuppressive marrow niche.
Positioning
Development positioning
2L+—2L+ (originally 4L+)
Technology
Vector
RetrovirusLentivirusLentiviral
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.Autologous T cells engineered with a dual-epitope BCMA CAR recognize BCMA on malignant plasma cells and trigger MHC-independent cytolysis and clonal CAR-T expansion.
MoA
Biomarker
CD19 expression on lymphoma cells; CAR T expansion in blood.CD19; measurable residual disease in ALL.BCMA expression, MRD negativity at 10⁻⁵, CAR transgene persistence.
Toxicology
Species
—Mouse—
Toxicology
Animal (cat.)
UnknownHuman—
Toxicology
Major finding
CRS, ICANS, cytopeniasCRS and neurological events; hypogammaglobulinemia from B-cell aplasia.Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.
Toxicology
CRS
Grade ≥3 ~13%CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocolCRS in ~95% of CARTITUDE-1 patients, grade ≥3 ~4%
Clinical
Safety signal
CRS, ICANS, cytopeniasCRS and neurological events; hypogammaglobulinemia from B-cell aplasia.Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.
Clinical
Program phase
APPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts