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항목
AntibodyCurated CorestalePhase 3
Blinatumomab (Blinatumomab)
Amgen·Precursor Cell Lymphoblastic Leuke…
115 trials
Overview
Program
Blinatumomab
Overview
Company
Amgen
Overview
Modality
ANTIBODY
Overview
Target
Precursor Cell Lymphoblastic Leukemia-Ly
Overview
Indication
B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
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 mechanisms of action that traditional monoclonal antibodies cannot achieve
Positioning
Known limitation
bypasses CD28 blockade to sustain T-cell cytotoxicity and improve survival in a xenograft B-ALL model
MoA
Mechanism
targeting CD19/20/22 and engineered chimeric antigen receptor
MoA
Biomarker
CD19 expression, whereas cytoplasmic CD22 expression
PK/PD
Species
Mouse
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse
Toxicology
Animal (cat.)
Mouse, In vitro
Toxicology
Major finding
Blinatumomab administration in the outpatient setting: Safety and health care utilization.. Blinatumomab, a bispecific CD19 × CD3 antibody is effective for the treatment of B-cell acute lymphoblastic leukemia (ALL). Because of its immune toxicities, namely cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), the US Food and Drug Administration (F…
Toxicology
CRS
1%
Clinical
Safety signal
Blinatumomab administration in the outpatient setting: Safety and health care utilization.. Blinatumomab, a bispecific CD19 × CD3 antibody is effective for the treatment of B-cell acute lymphoblastic leukemia (ALL). Because of its immune toxicities, namely cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), the US Food and Drug Administration (F…
Clinical
Selected reported efficacy
10%
Clinical
Reported PFS
NA
Clinical
Reported OS
NA
Clinical
Result source
ClinicalTrials.gov NCT03298412
Clinical
Program phase
PHASE_3
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03298412