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타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-6 · 마지막 9월 2일

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API CSV26행 · 1개 프로그램

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항목
CGTCurated CoreFDAApproved
exagamglogene autotemcel (Casgevy, exa-cel, CTX001)
Vertex / CRISPR Therapeutics·BCL11A enhancer (CRISPR/Cas9) → Hb…
9 trials
Overview
Program
Casgevy (exagamglogene autotemcel)
Overview
Company
Vertex / CRISPR Therapeutics
Overview
Modality
CGT
Overview
Target
BCL11A enhancer (CRISPR/Cas9) → HbF
Overview
Indication
Sickle cell disease with recurrent VOCs; transfusion-dependent β-thalassemia
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
First approved CRISPR medicine; HbF induction vs lentiviral gene addition
Positioning
Known limitation
bypassing such limitations
Positioning
Development positioning
CRISPR competitor to Lyfgenia (lentiviral) in SCD
Technology
Vector
Electroporation of Cas9 RNP (no integrating viral vector for edit)
MoA
Mechanism
Ex vivo CRISPR/Cas9 editing of autologous CD34+ cells to disrupt BCL11A erythroid enhancer, reactivating fetal hemoglobin (HbF) in sickle cell disease.
MoA
Biomarker
HbF fraction, VOC rate, hospitalization days.
PK/PD
Species
Rat
PK/PD
Animal (cat.)
Rat
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Rat
Toxicology
Major finding
Conditioning-related cytopenias, mucositis, infection risk
Clinical
Safety signal
Conditioning-related cytopenias, mucositis, infection risk
Clinical
Program phase
APPROVED
Clinical
Trial activity
5 recruiting · 2 completed
Preclinical
Animal (cat.)
Rat