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현재 선택: 2 · 임상 갱신 필요 1

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API CSV32행 · 2개 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 CorestalePhase 3
Talquetamab (Talquetamab)
Janssen·FRα
40 trials
Overview
Program
Tecvayli (teclistamab)Talquetamab
Overview
Company
Johnson & JohnsonJanssen
Overview
Modality
ANTIBODYANTIBODY
Overview
Target
BCMA × CD3FRα
Overview
Indication
Relapsed or refractory multiple myelomaMyeloma Multiple; Plasma Cell Leukemia
Overview
Phase
APPROVEDPHASE_3
Overview
Status
APPROVEDDISCONTINUED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · High
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedInvestigational
Positioning
Key differentiator
No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma.first-in-class, T-cell-redirecting bispecific antibody targeting GPRC5D, a novel antigen highly expressed on malignant plasma cells wi
Positioning
Known limitation
BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion.resistance mechanisms
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., Clinical, and Translational Science
MoA
Biomarker
BCMA expression, MRD negativity, serum free light chain response.BCMA (teclistamab) demonstrated unexpectedly high
PK/PD
Half-life
~2–3 weeks at steady state
PK/PD
Species
Cynomolgus monkey, T-cell activation markers, cytokine profile, soluble BCMACynomolgus monkey, NHP, Mouse, Human
PK/PD
Animal (cat.)
Human, NHPHuman, Mouse, NHP, Monkey
PK/PD
Experiment
pharmacokineticpharmacokinetic
Toxicology
Species
MouseCynomolgus monkey, NHP, Mouse, Human
Toxicology
Animal (cat.)
Human, Mouse, NHP, Monkey
Toxicology
Major finding
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.thrombocytopenia was significantly increased in patients with RI
Toxicology
CRS
CRS ~72%, grade ≥3 ~0.6%Reported
Clinical
Safety signal
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.thrombocytopenia was significantly increased in patients with RI
Clinical
Selected reported efficacy
ORR 63%
Clinical
Reported ORR
63.0%
Clinical
Reported PFS
~11.3 mo
Clinical
Result source
MajesTEC-1 (NCT03145181 / NCT04557098)
Clinical
Program phase
APPROVEDPHASE_3
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03145181