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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
CGTCurated CoreFDAApproved
ciltacabtagene autoleucel (Carvykti, cilta-cel, LCAR-B38M, JNJ-68284528)
Johnson & Johnson / Legend Biotech·BCMA
29 trials·t½ Cellular expansion kinetics rather than classical half-life
AntibodyCurated CoreFDAApproved
linvoseltamab (Lynozyfic, REGN5458, linvoseltamab-gcpt)
Regeneron·BCMA × CD3
24 trials·t½ IgG-like, supporting weekly then less frequent dosing
Overview
Program
Tecvayli (teclistamab)Carvykti (ciltacabtagene autoleucel)Lynozyfic (linvoseltamab)
Overview
Company
Johnson & JohnsonJohnson & Johnson / Legend BiotechRegeneron
Overview
Modality
ANTIBODYCGTANTIBODY
Overview
Target
BCMA × CD3BCMABCMA × CD3
Overview
Indication
Relapsed or refractory multiple myelomaRelapsed or refractory multiple myelomaRelapsed or refractory multiple myeloma after ≥4 prior lines including a PI, an IMiD, and an anti-CD38 antibody
Overview
Phase
APPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVED
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 · Established
Overview
Approval status
FDA approvedFDA approvedFDA approved
Positioning
Key differentiator
No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma.Dual-epitope BCMA binding raises avidity and appears to sustain CAR-T persistence longer than single-domain designs.Response-adapted schedule can stretch to q4w after a deep response, so the compare with Tecvayli is visit burden and CRS step-up, not the antigen.
Positioning
Known limitation
BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion.BCMA loss or biallelic deletion, soluble BCMA shedding, T-cell exhaustion, and immunosuppressive marrow niche.BCMA loss or mutation, T-cell exhaustion, and prior BCMA-directed therapy.
Positioning
Development positioning
Class-defining BCMA engager; competes with Elrexfio and BCMA CAR-T.Best-in-class efficacy in BCMA CAR-T, ahead of Abecma on depth of response.Second approved BCMA engager after Tecvayli; dosing frequency is the operational split.
Technology
Vector
Lentiviral
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.Autologous T cells engineered with a dual-epitope BCMA CAR recognize BCMA on malignant plasma cells and trigger MHC-independent cytolysis and clonal CAR-T expansion.Binds BCMA on myeloma cells and CD3 on T cells, forming a cytolytic synapse that kills the plasma cell independent of native TCR specificity.
MoA
Biomarker
BCMA expression, MRD negativity, serum free light chain response.BCMA expression, MRD negativity at 10⁻⁵, CAR transgene persistence.BCMA expression is not a companion diagnostic; soluble BCMA is exploratory.
PK/PD
Half-life
~2–3 weeks at steady stateCellular expansion kinetics rather than classical half-lifeIgG-like, supporting weekly then less frequent dosing
PK/PD
Species
Cynomolgus monkey, T-cell activation markers, cytokine profile, soluble BCMAPeak CAR transgene level, MRD negativity, soluble BCMA declineORR, MRD, soluble BCMA
PK/PD
Animal (cat.)
Human, NHPHumanHuman
PK/PD
Experiment
pharmacokineticPK
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.Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.Boxed warning for CRS and neurologic toxicity including ICANS. Neutropenia, infection, and hypogammaglobulinemia dominate later cycles.
Toxicology
CRS
CRS ~72%, grade ≥3 ~0.6%CRS in ~95% of CARTITUDE-1 patients, grade ≥3 ~4%CRS common, mostly grade 1–2 with step-up
Clinical
Safety signal
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.Boxed warning for CRS and neurologic toxicity including ICANS. Neutropenia, infection, and hypogammaglobulinemia dominate later cycles.
Clinical
Selected reported efficacy
ORR 63%ORR 97%ORR 70%
Clinical
Reported ORR
63.0%97%70%
Clinical
Reported PFS
~11.3 moHR 0.26 vs standard care in CARTITUDE-4
Clinical
Reported OS
NA
Clinical
Result source
MajesTEC-1 (NCT03145181 / NCT04557098)CARTITUDE-1 (NCT03548207) / CARTITUDE-4 (NCT04181827)LINKER-MM1 (NCT03761108)
Clinical
Program phase
APPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT03145181NCT03548207NCT03761108