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항목
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
Overview
Program
Carvykti (ciltacabtagene autoleucel)
Overview
Company
Johnson & Johnson / Legend Biotech
Overview
Modality
CGT
Overview
Target
BCMA
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
Dual-epitope BCMA binding raises avidity and appears to sustain CAR-T persistence longer than single-domain designs.
Positioning
Known limitation
BCMA loss or biallelic deletion, soluble BCMA shedding, T-cell exhaustion, and immunosuppressive marrow niche.
Positioning
Development positioning
Best-in-class efficacy in BCMA CAR-T, ahead of Abecma on depth of response.
Technology
Vector
Lentiviral
MoA
Mechanism
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.
MoA
Biomarker
BCMA expression, MRD negativity at 10⁻⁵, CAR transgene persistence.
PK/PD
Half-life
Cellular expansion kinetics rather than classical half-life
PK/PD
Species
Peak CAR transgene level, MRD negativity, soluble BCMA decline
PK/PD
Animal (cat.)
Human
PK/PD
Experiment
PK
Toxicology
Major finding
Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.
Toxicology
CRS
CRS in ~95% of CARTITUDE-1 patients, grade ≥3 ~4%
Clinical
Safety signal
Boxed warnings for CRS, ICANS, parkinsonism and Guillain-Barré syndrome, HLH/MAS, prolonged cytopenia, and secondary T-cell malignancy.
Clinical
Selected reported efficacy
ORR 97%
Clinical
Reported ORR
97%
Clinical
Reported PFS
HR 0.26 vs standard care in CARTITUDE-4
Clinical
Reported OS
NA
Clinical
Result source
CARTITUDE-1 (NCT03548207) / CARTITUDE-4 (NCT04181827)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03548207