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항목
AntibodyCurated CorestalePhase 3
Ofatumumab (Ofatumumab)
Novartis·Leukemia
85 trials
Overview
Program
Ofatumumab
Overview
Company
Novartis
Overview
Modality
ANTIBODY
Overview
Target
Leukemia
Overview
Indication
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Overview
Phase
PHASE_3
Overview
Status
RECRUITING
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Emerging
Overview
Approval status
Investigational
Positioning
Key differentiator
novel antibody approaches are needed
Positioning
Known limitation
resistance to these therapies inevitably develops in patients, and thus novel antibody approaches are needed
MoA
Mechanism
target cells with low antigen
MoA
Biomarker
biomarker-guided retreatment, infection-risk mitigation, and regimen adaptation for non-malignant disease
PK/PD
Species
Mouse, Rabbit
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse, Rabbit
Toxicology
Animal (cat.)
Mouse, In vitro
Toxicology
Major finding
thrombocytopenia, and liver damage associated with use of antibody-drug conjugates
Toxicology
CRS
Reported
Clinical
Safety signal
thrombocytopenia, and liver damage associated with use of antibody-drug conjugates
Clinical
Selected reported efficacy
ORR 78.4%
Clinical
Reported ORR
78.4%
Clinical
Result source
ClinicalTrials.gov NCT01088048
Clinical
Program phase
PHASE_3
Clinical
Trial ref
NCT01088048