Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0ZQBSG
ADC Name
MRG-001
Synonyms
MRG 001; MRG001
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Organization
Shanghai Miracogen Inc.; Lepu Biopharma Co., Ltd.
Drug Status
Phase 1
Indication
In total 1 Indication(s)
Non Hodgkin lymphoma [ICD11:2B33]
Phase 1
Drug-to-Antibody Ratio
4
Structure
Antibody Name
Chimeric Anti-CD20 mAb
  Antibody Info 
Antigen Name
B-lymphocyte antigen CD20 (MS4A1)
  Antigen Info 
Payload Name
Monomethyl auristatin E
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Combination Type
Vedotin
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT05155839
Phase 1
An open-label, multicenter, first-in-human, phase 1 dose-escalation and expansion clinical study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).

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Undisclosed  NCT05844527
Phase 2
Safety and efficacy of MRG-001 in wound healing in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing abdominoplasty.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
23.81% (among 21 pts who had at least one tumor assessment)
33.33% (in the 1.8 mg/kg cohort, DLBCL)
66.7% ( in the 2.5 mg/kg cohort, FL)
Patients Enrolled
CD20-positive relapsed or refractory (R/R) B-cell non Hodgkin lymphoma (NHL).
Administration Dosage
Six dose levels ranging from 0.15 to 2.50 mg/kg, intravenously once every 3 weeks (Q3W) for a maximum of 6 treatment cycles.
Related Clinical Trial
NCT Number NCT05155839  Clinical Status Phase 1
Clinical Description An open-label, multicenter, first-in-human, phase 1 dose-escalation and expansion clinical study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
Primary Endpoint
Rp2D=1.80 mg/kg.
Other Endpoint
Among 21 pts who had at least one tumor assessment, ORR=23.81% , PR rate=19.05% (N=4),CR rate=4.76% (N=1).
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05844527  Clinical Status Phase 2
Clinical Description Safety and efficacy of MRG-001 in wound healing in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing abdominoplasty.
References
Ref 1 A Dose Escalation Phase Ia Study of Anti-CD20 Antibody Drug Conjugate, MRG001 in Relapsed/Refractory Advanced Non-Hodgkin Lymphom. Blood. (2021) 138 (Supplement 1): 2490.
Ref 2 Safety and Efficacy of MRG-001 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions, NCT05844527

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