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항목
AntibodyCurated CoreFDAApproved
daratumumab (Darzalex)
Janssen·CD38
454 trials·t½ 20 h
Overview
Program
Darzalex (daratumumab)
Overview
Company
Janssen
Overview
Modality
ANTIBODY
Overview
Target
CD38
Overview
Indication
Multiple myeloma
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Direct on-tumor + immunomodulatory effects
Positioning
Known limitation
CD38 downregulation, high tumor burden, and impaired effector function after prior lines.
MoA
Mechanism
Daratumumab binds CD38 on plasma cells and other immune cells, inducing direct apoptosis, Fc-mediated ADCC/CDC, and immunomodulatory effects including depletion of CD38+ regulatory cells and enhanced T-cell clonality.
MoA
Biomarker
CD38 expression on clonal plasma cells (universal in MM).
PK/PD
Half-life
20 h
PK/PD
Species
Mouse, Human, M-protein, FLC, minimal residual disease, immunophenotypic CD38 saturation
PK/PD
Animal (cat.)
Human, Mouse
PK/PD
Experiment
pd
Toxicology
Species
Cynomolgus monkey, Mouse, Human
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate.
Toxicology
CRS
N/A
Clinical
Safety signal
Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate.
Clinical
Selected reported efficacy
ORR 35.3%
Clinical
Reported ORR
35.3%
Clinical
Result source
ClinicalTrials.gov NCT02990338
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT02990338