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현재 선택: 3 · 임상 갱신 필요 1

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API CSV33행 · 3개 프로그램

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항목
AntibodyCurated CoreFDAApproved
glofitamab (Columvi, RO7082859, glofitamab-gxbm)
Roche / Genentech·CD20 × CD3
90 trials·t½ ~1–2 weeks
AntibodyCurated CoreFDAApproved
epcoritamab (Epkinly, GEN3013, Tepkinly, epcoritamab-bysp)
Genmab / AbbVie·CD20 × CD3
57 trials·t½ ~3 weeks at steady state
AntibodyCurated CorestalePhase 3
Mosunetuzumab (Mosunetuzumab)
Epizyme, Inc.·FRα
49 trials
Overview
Program
Columvi (glofitamab)Epkinly (epcoritamab)Mosunetuzumab
Overview
Company
Roche / GenentechGenmab / AbbVieEpizyme, Inc.
Overview
Modality
ANTIBODYANTIBODYANTIBODY
Overview
Target
CD20 × CD3CD20 × CD3FRα
Overview
Indication
Relapsed or refractory diffuse large B-cell lymphomaRelapsed or refractory diffuse large B-cell lymphoma and follicular lymphomaRelapsed Hematologic Malignancy; Refractory Hematologic Malignancy
Overview
Phase
APPROVEDAPPROVEDPHASE_3
Overview
Status
APPROVEDAPPROVEDRECRUITING
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 approvedFDA approvedInvestigational
Positioning
Key differentiator
Bivalent CD20 binding increases avidity; obinutuzumab pretreatment debulks circulating B cells to blunt first-dose CRS.Subcutaneous dosing gives slower Cmax and lower grade ≥3 CRS than IV engagers.novel aspects of time toxicity, demonstrate clinically meaningful differences in time burden associated with BsAbs and emphas
Positioning
Known limitation
CD20 loss after prior anti-CD20 therapy and T-cell exhaustion.CD20 antigen loss and exhausted effector T cells after multiple prior lines.bypassing MHC presentation
Positioning
Development positioning
Competes with Epkinly on schedule and route; fixed duration is its main claim.Main SC alternative to Columvi, with continuous rather than fixed duration.
MoA
Mechanism
Crosslinks CD20 on malignant B cells with CD3 on T cells; the 2:1 geometry stabilizes the synapse and drives T-cell activation and B-cell lysis.Bispecific binding of CD20 on B cells and CD3 on T cells creates a cytolytic synapse; the silenced Fc prevents Fcγ-receptor-driven off-target activation., pharmacokinetic properties, and key clinical efficacy and safety data from the ELM-1 and ELM-2 trials, which supported its approval by the European Medicines Agency (EMA)
MoA
Biomarker
CD20 expression; ctDNA clearance investigational.CD20 expression; ctDNA MRD investigational.CD20 RO% was high
PK/PD
Half-life
~1–2 weeks~3 weeks at steady state
PK/PD
Species
Cynomolgus monkey, B-cell depletion, cytokine profile, PET-CRCynomolgus monkey, Peripheral B-cell depletion, cytokine kinetics, PET responseMouse, Human
PK/PD
Animal (cat.)
Human, NHPHuman, NHP, In vitroHuman, Mouse
PK/PD
Experiment
Pharmacodynamicpharmacokineticpharmacokinetic
Toxicology
Species
Cynomolgus monkey, MouseCynomolgus monkeyCynomolgus monkey, Mouse, Human
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Boxed warning for CRS. Neurologic events, infection, neutropenia, and tumor flare require monitoring.Boxed warning for CRS and ICANS. Injection-site reactions, neutropenia, and infection are common.thrombocytopenia [see Adverse Reactions (6
Toxicology
CRS
CRS ~63%, grade ≥3 ~4%CRS ~50%, grade ≥3 ~2.5%39%
Clinical
Safety signal
Boxed warning for CRS. Neurologic events, infection, neutropenia, and tumor flare require monitoring.Boxed warning for CRS and ICANS. Injection-site reactions, neutropenia, and infection are common.thrombocytopenia [see Adverse Reactions (6
Clinical
Selected reported efficacy
ORR 35.3%ORR 61%ORR 87.5%
Clinical
Reported ORR
35.3%61% (DLBCL)95.0%
Clinical
Reported PFS
NA
Clinical
Result source
ClinicalTrials.gov NCT04313608EPCORE NHL-1 (NCT03625037)ClinicalTrials.gov NCT03677141
Clinical
Program phase
APPROVEDAPPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04313608NCT03625037NCT03677141
Preclinical
Animal (cat.)
NHPHuman, NHP, Monkey, In vitro