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API CSV33행 · 3개 프로그램

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항목
AntibodyCurated CoreFDAApproved
teclistamab (Tecvayli, JNJ-64007957, teclistamab-cqyv)
Johnson & Johnson·BCMA × CD3
132 trials·t½ ~2–3 weeks at steady state
AntibodyCurated CorestaleApproved
Elranatamab (Elranatamab)
Pfizer·FRα
54 trials
AntibodyCurated CorestalePhase 3
Blinatumomab (Blinatumomab)
Amgen·Precursor Cell Lymphoblastic Leuke…
115 trials
Overview
Program
Tecvayli (teclistamab)ElranatamabBlinatumomab
Overview
Company
Johnson & JohnsonPfizerAmgen
Overview
Modality
ANTIBODYANTIBODYANTIBODY
Overview
Target
BCMA × CD3FRαPrecursor Cell Lymphoblastic Leukemia-Ly
Overview
Indication
Relapsed or refractory multiple myelomaMultiple MyelomaB Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Overview
Phase
APPROVEDAPPROVEDPHASE_3
Overview
Status
APPROVEDRECRUITINGRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · HighData Confidence · High
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedApproved (flag incomplete)Investigational
Positioning
Key differentiator
No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma.novel ALPS (Anemia-LDH Prognostic System) score, which stratified patients into distinct risk groups for ORR, OS, PFS, and dunovel mechanisms of action that traditional monoclonal antibodies cannot achieve
Positioning
Known limitation
BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion.resistance to available treatmentsbypasses CD28 blockade to sustain T-cell cytotoxicity and improve survival in a xenograft B-ALL model
Positioning
Development positioning
Class-defining BCMA engager; competes with Elrexfio and BCMA CAR-T.
MoA
Mechanism
Simultaneously engages BCMA on plasma cells and CD3 on T cells, forming an immune synapse that redirects polyclonal T cells to lyse BCMA+ myeloma cells independent of TCR specificity.targeting both B-cell maturation antigentargeting CD19/20/22 and engineered chimeric antigen receptor
MoA
Biomarker
BCMA expression, MRD negativity, serum free light chain response.BCMA-targeted therapies and feasibility in selected highCD19 expression, whereas cytoplasmic CD22 expression
PK/PD
Half-life
~2–3 weeks at steady state
PK/PD
Species
Cynomolgus monkey, T-cell activation markers, cytokine profile, soluble BCMAMouse, HumanMouse
PK/PD
Animal (cat.)
Human, NHPHuman, MouseMouse, In vitro
PK/PD
Experiment
pharmacokineticPharmacokineticpharmacokinetic
Toxicology
Species
MouseMouse, HumanMouse
Toxicology
Animal (cat.)
UnknownMouse, In vitro
Toxicology
Major finding
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.Hepatotoxicity : Can cause elevated ALT, AST, and bilirubinBlinatumomab 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
CRS ~72%, grade ≥3 ~0.6%58%1%
Clinical
Safety signal
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.Hepatotoxicity : Can cause elevated ALT, AST, and bilirubinBlinatumomab 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
ORR 63%ORR 61%10%
Clinical
Reported ORR
63.0%56.0%
Clinical
Reported PFS
~11.3 moNA
Clinical
Reported OS
NA
Clinical
Result source
MajesTEC-1 (NCT03145181 / NCT04557098)ClinicalTrials.gov NCT05565391ClinicalTrials.gov NCT03298412
Clinical
Program phase
APPROVEDAPPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT03145181NCT05565391NCT03298412