Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0ZQBSG
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| ADC Name |
MRG001
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| Synonyms |
MRG001
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| Organization |
Miracogen (Originator)
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| Drug Status |
Phase 2 (discontinued)
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Chimeric anti-CD20 mAb
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Antibody Info | ||||
| Antigen Name |
B-lymphocyte antigen CD20 (MS4A1)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
vedotin
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
|---|---|---|---|---|---|---|---|---|---|
| Unspecific non-hodgkin lymphoma |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) | 274 | ng/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 2 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1598 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 302 | ng/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 1 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1846 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 601 | ng/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 2 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4171 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 613 | ng/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 1 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4336 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 947 | ng/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 2 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 7325 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 1115 | ng/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 1 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8916 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 1.47 | ng/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 7.5 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 46.4 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 2.09 | ng/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 10 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 70.1 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 3.15 | ng/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 12 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 105 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 5.37 | ng/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 5.5 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 171 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 4.49 | ng/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 8.01 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 152 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Maximum Observed Concentration (Cmax) | 7.91 | ng/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Time to Maximum Concentration (Tmax) | 2 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 237 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 1598 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1846 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4171 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4336 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 7325 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8916 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 46.4 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 70.1 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 105 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 171 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 152 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 237 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 1598 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1846 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4171 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4336 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 7325 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8916 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 46.4 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 70.1 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 105 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 171 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 152 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 237 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 1598 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 3.29 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1846 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 4.56 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4171 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 4.26 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4336 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 4.56 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 7325 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 5.01 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8916 | ng*h/mL |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 6.06 | h |
Summary of Plerixafor Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 46.4 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 23.8 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 70.1 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 24.9 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.005 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 105 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 37.8 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 171 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 29.5 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.01 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 152 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 36.4 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 1, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 237 | ng*h/mL |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg, AUCtau.
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[1] |
| Elimination Half-Life (t1/2) | 30.6 | h |
Summary of Tacrolimus Pharmacokinetic Parameters on Day 5, Cohort 1
MRG-001 0.02 mL/kg.
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[1] |
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
23.81
33.33 66.70 % |
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| Patients Enrolled |
CD20-positive relapsed or refractory (R/R) B-cell non Hodgkin lymphoma (NHL).
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| 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.
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| 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.
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| 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).
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| 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. | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients (18-80 years) had relapsed/refractory B-cell NHL post-anti-CD20 therapy, ≥1 measurable lesion (Lugano 2014), ECOG 0-1, adequate organ function, and resolved prior toxicities (≤Grade 1). Exclusions: active HBV/HCV/HIV infection, uncontrolled infections/cardiovascular/pulmonary diseases, recent CAR-T/transplant/vaccines, concomitant CYP3A4 modulators, pregnancy/lactation, or conditions increasing study risk per investigator judgment. Phase Ia/Ib had specific hepatitis criteria.
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| Administration Dosage |
All patients in Phase Ia (dose escalation) and Phase Ib (dose expansion) will be administrated MRG001 on Day 1 of every 3 weeks (21-day cycle).
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| Related Clinical Trial | |||||
| NCT Number | NCT05155839 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-label, Multicenter, First-in-human, Phase I 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 |
This study evaluates safety and dosing through adverse events (AEs) recorded from baseline to 90 days post-treatment, maximum tolerated dose (MTD) defined by ≤1/6 patients experiencing dose-limiting toxicities (DLTs) in Cycle 1, and the establishment of a recommended Phase II dose (RP2D) for MRG001.
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| Other Endpoint |
Secondary assessments include pharmacokinetics (concentration-time curves), immunogenicity (ADA positivity), and efficacy measures: objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)-tracked for up to 15 months from baseline.
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| Experiment 4 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible adults (≥21 years) with recent-onset jaundice and heavy alcohol use (≥40g/day females, ≥60g/day males) must meet AH biochemical criteria (bilirubin >3mg/dL, AST 50-400 IU/L, MELD 21-30). Exclusions: concurrent liver diseases (viral/autoimmune), active infections, uncontrolled GI bleeding, severe organ dysfunction (EF <20%, platelets <30K/mm <sup>3</sup>, hepatic encephalopathy ≥3), malignancies (<5 years), HIV/TB co-infection, transplant recipients, or hypersensitivity to MRG-001 components. Women must use contraception.
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| Administration Dosage |
.
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| Related Clinical Trial | |||||
| NCT Number | NCT06307522 | Clinical Status | PHASE2 | ||
| Clinical Description | An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis | ||||
| Primary Endpoint |
The study evaluates MRG-001's safety and tolerability in alcoholic hepatitis (AH) patients by monitoring treatment-emergent adverse events (TEAEs) over 28 days, with SUSAR reporting as a key safety measure.
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| Other Endpoint |
Pharmacokinetic analysis focuses on MRG-001's PK profile (trough levels of plerixafor/tacrolimus), while pharmacodynamic effects are assessed via flow cytometry to track CD34+ stem cell mobilization vs. baseline during the 28-day period.
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| Experiment 5 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Eligible patients (18-75 years) must have ALS (El Escorial criteria, symptom onset ≤48 months), ≥50% predicted vital capacity, and stable/no use of riluzole/edaravone/Relyvrio. Exclusions: organ dysfunction (e.g., EF <20%, platelets <30K/mm <sup>3</sup>, CrCl <50 mL/min), active cancer (exceptions apply), psychiatric/cognitive impairment, prior ALS gene therapy, HIV, transplants, immunosuppressants (except steroids), pregnancy, or MRG-001 hypersensitivity.
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| Administration Dosage |
MRG-001 will be subcutaneously administered at 0.01 mL/kg 3 times per week every other day for two weeks per month (Day 0, 2, 4, 7, 9, 11). This cycle will be repeated 3 months in total.
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| Related Clinical Trial | |||||
| NCT Number | NCT06315608 | Clinical Status | PHASE2 | ||
| Clinical Description | An Open-Label, Proof of Concept Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Amyotrophic Lateral Sclerosis | ||||
| Primary Endpoint |
The study evaluates the safety of MRG-001 in ALS patients over a 3-month period by monitoring treatment-emergent adverse events, with absence of serious adverse events (SAEs) as the primary safety endpoint.
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| Other Endpoint |
Key secondary endpoints include stem cell mobilization (CD34+ count change at 24h), regulatory T-cell response (FOXP3+ count change at 24h), and disease progression (ALSFRS-R score at 0/1/2/3 months-higher scores indicate better function; positive/negative changes reflect reversal/worsening of ALS).
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| Experiment 6 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Eligible participants (18-55 years) are healthy non-smokers (BMI 25-35) undergoing elective abdominoplasty. Exclusions: recent investigational drug use, diabetes (HbA1C >5.7%), prior abdominal procedures, poor wound healing, collagen disorders, immunomodulatory therapy, pregnancy/breastfeeding, substance abuse, MRG-001 hypersensitivity, or situations compromising protocol adherence. Female participants must use contraception.
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| Administration Dosage |
MRG-001 will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT05844527 | Clinical Status | PHASE2 | ||
| Clinical Description | Safety and Efficacy of MRG-001 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions | ||||
| Primary Endpoint |
The study assesses the preliminary effectiveness of MRG-001 on scar tensile strength, comparing Newton force measurements between MRG-001 and saline treatments during Weeks -6 to 0.
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| Other Endpoint |
Safety, pharmacokinetics (Cmax, trough levels, clearance, t½), and pharmacodynamics (stem/immune cell presence in blood/tissue) of MRG-001 are evaluated versus placebo. Additional endpoints include time to wound re-epithelization (photographic assessment), scar appearance (modified POSAS), VAS pain scores, infection rates, and histological analysis of CD133+/CD34+/FOXP3+/macrophage cell populations in scars (Weeks -6 to 0).
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References