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API CSV29행 · 5개 프로그램

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항목
AntibodyCurated CoreFDAstaleApproved
teclistamab-cqyv (Tecvayli, JNJ-64007957, teclistamab)
Johnson & Johnson·BCMA × CD3
132 trials
AntibodyCurated CoreFDAstaleApproved
linvoseltamab (Lynozyfic, REGN5458, linvoseltamab-gcpt)
Regeneron·BCMA × CD3
24 trials·t½ IgG-like, supporting weekly then less frequent dosing
CGTCurated CoreFDAstaleApproved
ciltacabtagene autoleucel (Carvykti, cilta-cel, LCAR-B38M, JNJ-68284528)
Johnson & Johnson / Legend Biotech·BCMA
29 trials
ADCCurated CoreFDAstaleApproved
belantamab mafodotin (Blenrep, GSK2857916)
GSK·BCMA
78 trials
CGTLimited DatastalePhase 1
V001-BCMA (V001-BCMA)
Cancer Institute and Hospital, Chi…·BCMA
2 trials
Overview
Program
Tecvayli (teclistamab-cqyv)Lynozyfic (linvoseltamab)Carvykti (ciltacabtagene autoleucel)Blenrep (belantamab mafodotin)V001-BCMA
Overview
Company
Johnson & JohnsonRegeneronJohnson & Johnson / Legend BiotechGSKCancer Institute and Hospital, Chinese Academy of Medical Sciences
Overview
Modality
ANTIBODYANTIBODYCGTADCCGT
Overview
Target
BCMA × CD3BCMA × CD3BCMABCMABCMA
Overview
Indication
Relapsed or refractory multiple myelomaRelapsed or refractory multiple myeloma after ≥4 prior lines including a PI, an IMiD, and an anti-CD38 antibodyRelapsed or refractory multiple myelomaMultiple myelomaAdvanced Malignant Tumours
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_1
Overview
Status
APPROVEDAPPROVEDAPPROVEDDISCONTINUEDRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated CoreLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Watch
Overview
Approval status
FDA approvedFDA approvedFDA approvedFDA approvedInvestigational
Positioning
Key differentiator
No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma.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.Dual-epitope BCMA binding raises avidity and appears to sustain CAR-T persistence longer than single-domain designs.BCMA-targeted ADC with ocular AEs—
Positioning
Known limitation
BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion.BCMA loss or mutation, T-cell exhaustion, and prior BCMA-directed therapy.BCMA loss or biallelic deletion, soluble BCMA shedding, T-cell exhaustion, and immunosuppressive marrow niche.bypass this immune effector cell dependence, we developed a novel strategy using antibody-drug conjugates (ADCs)—
Positioning
Development positioning
5L+ (label), earlier in practice and ongoing trials4L+2L+ (originally 4L+)——
Technology
Payload
———MMAF—
Technology
Linker
———Non-cleavable—
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.Binds BCMA on myeloma cells and CD3 on T cells, forming a cytolytic synapse that kills the plasma cell independent of native 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.Belantamab mafodotin binds BCMA on plasma cells; afucosylated Fc enhances immune engagement while MMAF (microtubule inhibitor) payload is internalized and causes cell death.—
MoA
Biomarker
BCMA expression, MRD negativity, serum free light chain response.BCMA expression is not a companion diagnostic; soluble BCMA is exploratory.BCMA expression, MRD negativity at 10⁻⁵, CAR transgene persistence.BCMA expression on myeloma cells.—
PK/PD
Half-life
—IgG-like, supporting weekly then less frequent dosing———
PK/PD
Species
—ORR, MRD, soluble BCMA———
PK/PD
Animal (cat.)
—Human———
Toxicology
Species
———Mouse, Rat—
Toxicology
Animal (cat.)
———Human—
Toxicology
Major finding
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.Boxed warning for CRS and neurologic toxicity including ICANS. Neutropenia, infection, and hypogammaglobulinemia dominate later cycles.Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.Ocular toxicity (keratopathy, blurred vision) in majority of patients; thrombocytopenia and infusion reactions.—
Toxicology
CRS
CRS ~72%, grade ≥3 ~0.6%CRS common, mostly grade 1–2 with step-upCRS in ~95% of CARTITUDE-1 patients, grade ≥3 ~4%——
Clinical
Safety signal
Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity.Boxed warning for CRS and neurologic toxicity including ICANS. Neutropenia, infection, and hypogammaglobulinemia dominate later cycles.Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.Ocular toxicity (keratopathy, blurred vision) in majority of patients; thrombocytopenia and infusion reactions.—
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_1
Clinical
Trial activity
No active/completed counts—No active/completed countsNo active/completed counts—