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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
Overview
Program
Tecvayli (teclistamab)
Overview
Company
Johnson & Johnson
Overview
Modality
ANTIBODY
Overview
Target
BCMA × CD3
Overview
Indication
Relapsed or refractory 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
No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma.
Positioning
Known limitation
BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion.
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.
MoA
Biomarker
BCMA expression, MRD negativity, serum free light chain response.
PK/PD
Half-life
~2–3 weeks at steady state
PK/PD
Species
Cynomolgus monkey, T-cell activation markers, cytokine profile, soluble BCMA
PK/PD
Animal (cat.)
Human, NHP
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse
Toxicology
Major finding
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.
Toxicology
CRS
CRS ~72%, grade ≥3 ~0.6%
Clinical
Safety signal
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.
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
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03145181