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API CSV34행 · 3개 프로그램

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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
CGTCurated CoreFDAApproved
tisagenlecleucel (Kymriah, tisa-cel)
Novartis·CD19
48 trials
Overview
Program
Yescarta (axicabtagene ciloleucel)Kymriah (tisagenlecleucel)autologous CD19-directed chimeric antigen receptor (CAR) T-cells
Overview
Company
Kite / GileadNovartisAstraZeneca
Overview
Modality
CGTCGTCGT
Overview
Target
CD19CD19CD19
Overview
Indication
LBCL, FLALL, DLBCL, FLRelapsed Non Hodgkin Lymphoma; Relapsed Adult ALL
Overview
Phase
APPROVEDAPPROVEDPHASE_2
Overview
Status
APPROVEDAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreStandard Database
Overview
Data Confidence
Data Confidence · HighData Confidence · HighData Confidence · Medium
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedFDA approvedInvestigational
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
First mover in CD19 CAR-T LBCL
Technology
Vector
RetrovirusLentivirusAAV) but is clinically still in an early developmental stage
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.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 expression on lymphoma cells; CAR T expansion in blood.CD19; measurable residual disease in ALL.biomarkers such as body composition metrics
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 aplasiaNHP, CAR T transgene persistence, B-cell aplasiaDog, Human
PK/PD
Animal (cat.)
UnknownNHP, In vitroHuman, Dog, In vitro
PK/PD
Experiment
pharmacodynamicpharmacodynamicPD
Toxicology
Species
resistance, toxicity, and precision strategies.NHP, MouseDog, Human
Toxicology
Animal (cat.)
UnknownHumanHuman, Dog, In vitro
Toxicology
Major finding
CRS, ICANS, cytopeniasCRS and neurological events; hypogammaglobulinemia from B-cell aplasia.Clinical Pharmacology of Lisocabtagene Maraleucel in B-cell Malignancies.. Chimeric antigen receptor (CAR) T-cell therapies represent a distinct therapeutic modality whose clinical activity is governed by in vivo cellular kinetics. Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed, 4-1BB CAR T-cell product in which in vivo expansion plays an important role in clinical pharmacology…
Toxicology
CRS
Grade ≥3 ~13%CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocolReported
Clinical
Safety signal
CRS, ICANS, cytopeniasCRS and neurological events; hypogammaglobulinemia from B-cell aplasia.Clinical Pharmacology of Lisocabtagene Maraleucel in B-cell Malignancies.. Chimeric antigen receptor (CAR) T-cell therapies represent a distinct therapeutic modality whose clinical activity is governed by in vivo cellular kinetics. Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed, 4-1BB CAR T-cell product in which in vivo expansion plays an important role in clinical pharmacology…
Clinical
Selected reported efficacy
ORR 92%ORR 77.3%
Clinical
Reported ORR
94%77.3%
Clinical
Reported PFS
40.2
Clinical
Reported OS
NA088
Clinical
Result source
ClinicalTrials.gov NCT03105336ClinicalTrials.gov NCT04225676ClinicalTrials.gov NCT03642626
Clinical
Program phase
APPROVEDAPPROVEDPHASE_2
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT03105336NCT04225676NCT03642626