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항목
CGTStandard DatabasestalePhase 2
Relmacabtagene Autoleucel (Autoleucel, Autoleucel (Relmacabtagene Autoleucel))
Sun Yat-sen University·Large B Cell Diffuse Lymphoma
47 trials
Overview
Program
Autoleucel (Relmacabtagene Autoleucel)
Overview
Company
Sun Yat-sen University
Overview
Modality
CGT
Overview
Target
Large B Cell Diffuse Lymphoma
Overview
Indication
Large B Cell Diffuse Lymphoma; Mantle Cell Lymphoma (MCL)
Overview
Phase
PHASE_2
Overview
Status
RECRUITING
Overview
Content status
Standard Database
Overview
Data Confidence
Data Confidence · Medium
Overview
Development Signal
Development Signal · Emerging
Overview
Approval status
Investigational
MoA
Mechanism
targeted chimeric antigen receptor
MoA
Biomarker
biomarkers of CAR-T cell expansion, we analyzed absolute lymphocyte count (ALC) as a surrogate biomarker in a
PK/PD
Species
Human
PK/PD
Animal (cat.)
Human
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Human
Toxicology
Animal (cat.)
Human
Toxicology
Major finding
Epitope mapping of humoral immunogenicity of orvacabtagene autoleucel shows an IgM response with minimal impact on CAR T cellular kinetics.. Orvacabtagene autoleucel (orva-cel) is a fully human B cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T cell therapy evaluated in a phase 1/2 study in patients with relapsed or refractory multiple myeloma (RRMM). To assess treatment-r…
Toxicology
CRS
4%
Clinical
Safety signal
Epitope mapping of humoral immunogenicity of orvacabtagene autoleucel shows an IgM response with minimal impact on CAR T cellular kinetics.. Orvacabtagene autoleucel (orva-cel) is a fully human B cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T cell therapy evaluated in a phase 1/2 study in patients with relapsed or refractory multiple myeloma (RRMM). To assess treatment-r…
Clinical
Selected reported efficacy
ORR 38%
Clinical
Reported ORR
38.0%
Clinical
Reported PFS
3.5
Clinical
Reported OS
9.6
Clinical
Result source
ClinicalTrials.gov NCT05537766
Clinical
Program phase
PHASE_2
Clinical
Trial ref
NCT05537766