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현재 선택: 2 · 임상 갱신 필요 1 · Data Tier에서 열림

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API CSV31행 · 2개 프로그램

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항목
CGTCurated CoreFDAApproved
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
Data Confidence · HighData Confidence · Medium
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
PK/PD
Species
NHP, CAR T transgene persistence, B-cell aplasiaDog, Human
PK/PD
Animal (cat.)
NHP, In vitroHuman, Dog, In vitro
PK/PD
Experiment
pharmacodynamicPD
Toxicology
Species
NHP, MouseDog, Human
Toxicology
Animal (cat.)
HumanHuman, Dog, In vitro
Toxicology
Major finding
CRS 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
CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocolReported
Clinical
Safety signal
CRS 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 77.3%
Clinical
Reported ORR
77.3%
Clinical
Reported OS
088
Clinical
Result source
ClinicalTrials.gov NCT04225676ClinicalTrials.gov NCT03642626
Clinical
Program phase
APPROVEDPHASE_2
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04225676NCT03642626